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Cybersecurity Software Quality Engineer

Classification: Full Time
Location: Remote (must be US based)
Travel: Yes, candidate must have the desire and ability to travel

Position Summary:

Technical, hands-on role to support our rapidly expanding Quality Engineering team. A self-starter and a multi-tasker, this individual will work on multiple exciting projects in tandem, with limited supervision. While quality engineering including software development and cybersecurity experience in the medical device industry are must-haves, time management and communication are equally important.

Relocation to the Boston area is not required; successful candidate can work remotely from their home office and at client site as needed.

Essential Duties and Responsibilities: (will be variable depending on the nature of the client projects to be undertaken)

  • Work with clients to develop IEC 62304 compliant documentation (all software classifications).
  • Work with clients to meet security standards (e.g., ISO 27001, HiTrust, NIST, etc.).
  • Performing security audits and assessments.
  • Design History File audits for compliance to 21 CFR 820, ISO 13485, IEC 62304.
  • Serve as client cybersecurity SME and Software Quality Engineering function including assistance with cybersecurity deliverables as part of the software development process.
  • Must be able to assist clients with risk-based decisions using critical thinking.
  • Leading and mentoring Agile software teams integrating cybersecurity requirements within Software Development including:
    •  Development Lifecycle Planning integrating cybersecurity.
    • Requirement Development including Security requirements.
    • Hazard Analysis including Security Risk Management (Cybersecurity Threat Modeling, Anomaly Analysis, SBOM, Threat mitigation).
    • Verification documentation methods (Vulnerability and Pen testing, fuzzing and custom exploit attacks against client medical systems; Automated and Manual testing).
    • Cybersecurity Post-market monitoring including labeling requirements and vulnerability management.
  • Plan and Identify client processes that may require improvement, correction, or additional contracted resources.
  • Successfully plan and manage multiple, parallel projects to successful completion, on time and within budget.
  • Develop strong relationships with clients, providing timely and accurate communications.

Skills Requirements:

  • Bachelor's degree in Computer Science, Cybersecurity, or in a closely related / equivalent field.
  • Minimum five years of experience in software quality engineering including cybersecurity within the Medical Device industry.
  • Proven knowledge of medical equipment cybersecurity principles and documentation.
  • Experience with security standards such as ISO 27001, HiTrust, NIST, etc.
  • Knowledge of Bluetooth, IoT, and mobile devices.
  • Security certifications (CISSP, CISM, CRISC, or CISA) a plus.
  • Awareness of security trends in process, tooling and threats.
  • Experience with implementation of ISO 13485, ISO 14971, and IEC 62304.
  • Working knowledge of ISO 14971, Part 11, IEC 60601, Human Factors, ISO 13485, FDA Quality System Regulation, and EU MDR.
  • Hands-on ability to work autonomously to problem-solve.
  • Excellent communication, time management, and analytical skills required.
  • Experience with small / startup company desired.
  • Electromechanical experience a plus, including knowledge of IEC 60601.
  • Experience with regulatory submission content creation a plus.
  • Must possess excellent verbal, time management, and written communications skills.
  • Previous consulting and clientele relationship experience a plus.

Please note the following:

  • Applicants for this position must be legally authorized to work in the U.S.
  • We are not currently sponsoring work visas.
  • Relocation is not available for this position as it is a remote role.
  • We are an Equal Employment Opportunity employer. Drug free workplace.
  • We are following all state guidelines relative to safety precautions.

APPLY NOW

Electromechanical Quality Engineer

Classification: Full Time
Location: Remote (must be US based)
Travel: Yes, candidate must have the desire and ability to travel

Position Summary:

Technical, hands-on role to support our rapidly expanding Quality Engineering team. A self-starter and a multi-tasker, this individual will work on multiple exciting projects in tandem, with limited supervision. While electromechanical quality engineering including IEC 60601, RMF, and DHF compliance in the medical device industry are must-haves, time management and communication are equally important.

Relocation to the Boston area is not required; successful candidate may work remotely from their home office and at client site as needed.

Essential Duties and Responsibilities: (will be variable depending on the nature of the client projects to be undertaken

  • Work with clients to develop IEC 60601, ISO 13485, 21 CFR 820, EU MDR compliant documentation (all product classifications).
  • Able to review to assure RMF meets requirements of IEC 60601 and ISO 14971.
  • Design History File audits for compliance to IEC 60601, 21 CFR 820, ISO 13485, IEC 62304.
  • Serve as client Quality Engineer with expertise in electromechanical products including assistance with product design development documents, risk management files, manufacturing process validation, and inspection documentation.
  • Must be able to assist clients with risk-based decisions using critical thinking.
  • Identify client processes that may require improvement, correction, or additional contracted resources.
  • Successfully plan and manage multiple, parallel projects to successful completion, on time and within budget.
  • Develop strong relationships with clients, providing timely and accurate communications.

Skills Requirements:

  • Bachelor's degree in Electrical Engineering or in a closely related / equivalent.
  • Minimum five years of experience in quality engineering including electromechanical products within the Medical Device industry.
  • Proven hands-on electromechanical product experience including implementing compliance to IEC 60601 (including sub-sections).
  • Hardware and Software experience, more on the Electrical Engineering side.
  • Working knowledge of ISO 13485, ISO 14971, IEC 62304, IEC 62366, FDA Quality System Regulation, and EU MDR.
  • Hands-on ability to work autonomously and learn on the fly to problem-solve.
  • Excellent communication, time management, and analytical skills required.
  • Experience with small / startup company desired.
  • Cybersecurity experience a plus.
  • Experience with regulatory submission content creation a plus.
  • Must possess excellent verbal, time management, and written communications skills.
  • Previous consulting and clientele relationship experience a plus.

Please note the following:

  • Applicants for this position must be legally authorized to work in the U.S.
  • We are not currently sponsoring work visas.
  • Relocation is not available for this position as it is a remote role.
  • We are an Equal Employment Opportunity employer. Drug free workplace.
  • We are following all state guidelines relative to safety precautions.

APPLY NOW

    Quality Systems Senior Consultant

    Classification: Full Time
    Location: Remote (must be US based)
    Travel: Yes, ~50% 

    Position Summary:

    The Quality Systems Senior Consultant is a hands-on role supporting the Quality Management Systems department. Must be a self-starter and a multi-tasker, as this position will work on multiple exciting client projects in tandem.

    Essential Duties and Responsibilities: (will be variable depending on the nature of the client projects to be undertaken)

    • Successfully develop and manage Quality Management Systems to meet FDA QSR, ISO 13485, EU MDR, MDSAP, and other applicable regulatory requirements.
    • Conduct / lead / assist clients with internal, supplier, ISO 13485, CE Mark, MDSAP audits and FDA inspections.
    • Perform recidivist certification and due diligence audits.
    • Compliance strategy development, including enforcement action responses and/or corrective action plans (483s, warning letters, etc.), recall strategies.
    • Supplier Quality Management activities, including supplier audits and corrective action process.
    • Deliver customized client training and education programs.
    • Corrective action strategy and development.
    • Preparation for FDA inspections and registrar or Notified Body assessments.
    • Identify client processes that may require improvement, correction, or additional contracted resources.
    • Successfully plan, manage, execute, and close turnkey projects within budget, and on time.
    • Develop strong relationship with clients, providing timely and accurate communications.
    • Deliver customized client training and education programs on Quality Management Systems and other industry topics.
    • Potentially serves client adjunct quality staffing (Interim Quality Professional)

    Skills Requirements:

    • Bachelor’s degree in Engineering, Regulatory and Compliance Management, Quality Engineering, or in a closely related / equivalent field.
    • Minimum ten (10) years of experience monitoring and maintaining quality management systems to ensure compliance with government regulations within the medical device, pharmaceutical, biotechnology, etc.
    • Former FDA Investigator or Notified Body (ISO) Assessor experience a must.
    • Auditor and in-depth knowledge and experience working with 21 CFR Parts 4, 820, 210/211, 803, 806 and ISO 13485, 14971, EU MDR, EU IVDR and related International Requirements.
    • Lead Auditor certification a plus.
    • Excellent communication (oral, written and verbal) and time management skills required.
    • Must be detail-oriented, thorough, and organized.
    • Excellent interpersonal skills with a customer service focus.
    • Ability to manage multiple projects simultaneously.
    • Must be self-motivated, able to work both independently and with a team.
    • Software (ISO 62304) and Usability (ISO 62366) experience a plus.
    • Project Management experience a plus.

    Please note the following:

    • Applicants for this position must be legally authorized to work in the U.S.
    • We are not currently sponsoring work visas.
    • Relocation is not available for this position as it is a remote role.
    • We are an Equal Employment Opportunity employer. Drug free workplace.
    • We are following all state guidelines relative to safety precautions.

    APPLY NOW

    Quality Systems Consultant

    Classification: Full Time
    Location: Remote (must be US based)
    Travel: Yes, ~50% 

    Position Summary:

    The Quality Systems Consultant is a hands-on role supporting the Quality Management Systems department. Must be a self-starter and a multi-tasker, as this position will work on multiple exciting client projects in tandem.

    Essential Duties and Responsibilities: (will be variable depending on the nature of the client projects to be undertaken)

    • Successfully develop and manage Quality Management Systems to meet FDA QSR, ISO 13485, EU MDR, MDSAP, and other applicable regulatory requirements.
    • Conduct / lead / assist clients with internal, supplier, ISO 13485, CE Mark, MDSAP audits and FDA inspections.
    • Perform recidivist certification and due diligence audits.
    • Compliance strategy development, including enforcement action responses and/or corrective action plans (483s, warning letters, etc.), recall strategies.
    • Supplier Quality Management activities, including supplier audits and corrective action process.
    • Deliver customized client training and education programs.
    • Corrective action strategy and development.
    • Preparation for FDA inspections and registrar or Notified Body assessments.
    • Identify client processes that may require improvement, correction, or additional contracted resources.
    • Successfully plan, manage, execute, and close turnkey projects within budget, and on time.
    • Develop strong relationship with clients, providing timely and accurate communications.
    • Deliver customized client training and education programs on Quality Management Systems and other industry topics.
    • Potentially serve as client adjunct quality staffing (Interim Quality Professional).

    Skills Requirements:

    • Bachelor’s degree in Engineering, Regulatory and Compliance Management, Quality Engineering, or in a closely related / equivalent field.
    • Minimum five (5) years of experience monitoring and maintaining quality management systems to ensure compliance with government regulations within the medical device, life sciences industry.
    • Auditing and in-depth knowledge and experience working with 21 CFR Parts 820, 803, 806 and ISO 13485, ISO 9001, EU MDR and related International Requirements.
    • Lead Auditor or Auditor certification a plus.
    • Proven hands-on experience with document management, training, CAPA, electronic system development/validation, management review, risk management, and quality improvement initiatives.
    • Excellent communication (oral, written and verbal) and time management skills required.
    • Must be detail-oriented, thorough, and organized.
    • Excellent interpersonal skills with a customer service focus.
    • Ability to manage multiple projects simultaneously.
    • Must be self-motivated, able to work both independently and with a team.
    • Software (ISO 62304) and Usability (ISO 62366) experience a plus.
    • Project Management experience a plus.

    Please note the following:

    • Applicants for this position must be legally authorized to work in the U.S.
    • We are not currently sponsoring work visas.
    • Relocation is not available for this position as it is a remote role.
    • We are an Equal Employment Opportunity employer. Drug free workplace.
    • We are following all state guidelines relative to safety precautions.

    APPLY NOW

    Quality Systems Consultant – West Coast

    Classification: Full Time
    Location: Remote, West Coast (must be US based)
    Travel: Yes, ~50%

    Position Summary:

    The Quality Systems Consultant is a hands-on role supporting the Quality Management Systems department. Must be a self-starter and a multi-tasker, as this position will work on multiple exciting client projects in tandem.

    Essential Duties and Responsibilities: (will be variable depending on the nature of the client projects to be undertaken)

    • Successfully develop and manage Quality Management Systems to meet FDA QSR, ISO 13485, EU MDR, MDSAP, and other applicable regulatory requirements.
    • Conduct / lead / assist clients with internal, supplier, ISO 13485, CE Mark, MDSAP audits and FDA inspections.
    • Perform recidivist certification and due diligence audits.
    • Compliance strategy development, including enforcement action responses and/or corrective action plans (483s, warning letters, etc.), recall strategies.
    • Supplier Quality Management activities, including supplier audits and corrective action process.
    • Deliver customized client training and education programs.
    • Corrective action strategy and development.
    • Preparation for FDA inspections and registrar or Notified Body assessments.
    • Identify client processes that may require improvement, correction, or additional contracted resources.
    • Successfully plan, manage, execute, and close turnkey projects within budget, and on time.
    • Develop strong relationship with clients, providing timely and accurate communications.
    • Deliver customized client training and education programs on Quality Management Systems and other industry topics.
    • Potentially serve as client adjunct quality staffing (Interim Quality Professional).

    Skills Requirements:

    • Bachelor’s degree in Engineering, Regulatory and Compliance Management, Quality Engineering, or in a closely related / equivalent field.
    • Minimum five (5) years of experience monitoring and maintaining quality management systems to ensure compliance with government regulations within the medical device, life sciences industry.
    • Auditing and in-depth knowledge and experience working with 21 CFR Parts 820, 803, 806 and ISO 13485, ISO 9001, EU MDR and related International Requirements.
    • Lead Auditor or Auditor certification a plus.
    • Proven hands-on experience with document management, training, CAPA, electronic system development/validation, management review, risk management, and quality improvement initiatives.
    • Excellent communication (oral, written and verbal) and time management skills required.
    • Must be detail-oriented, thorough, and organized.
    • Excellent interpersonal skills with a customer service focus.
    • Ability to manage multiple projects simultaneously.
    • Must be self-motivated, able to work both independently and with a team.
    • Software (ISO 62304) and Usability (ISO 62366) experience a plus.
    • Project Management experience a plus.

    Please note the following:

    • Applicants for this position must be legally authorized to work in the U.S.
    • We are not currently sponsoring work visas.
    • Relocation is not available for this position as it is a remote role.
    • We are an Equal Employment Opportunity employer. Drug free workplace.
    • We are following all state guidelines relative to safety precautions.

    APPLY NOW

    Quality Systems Consultant – Europe

    Classification: Full Time
    Location: Europe, must be fluent in German and English
    Travel: Yes, candidate must have the desire and ability to travel

    Position Summary

    The Quality Systems Consultant is a hands-on role supporting the Quality Management Systems department. Must be a self-starter and a multi-tasker, as this position will work on multiple exciting client projects in tandem.

    Essential Duties and Responsibilities: (will be variable depending on the nature of the client projects to be undertaken)

    • Successfully develop and manage Quality Management Systems to meet FDA QSR, ISO 13485, EU MDR, MDSAP, and other applicable regulatory requirements.
    • Conduct / lead / assist clients with internal, supplier, ISO 13485, CE Mark, MDSAP audits, and FDA inspections.
    • Perform recidivist certification and due diligence audits.
    • Compliance strategy development, including enforcement action responses and/or corrective action plans (483s, warning letters, etc.), recall strategies.
    • Supplier Quality Management activities, including supplier audits and corrective action process.
    • Deliver customized client training and education programs.
    • Corrective action strategy and development.
    • Preparation for FDA inspections and registrar or Notified Body assessments.
    • Identify client processes that may require improvement, correction, or additional contracted resources.
    • Successfully plan, manage, execute, and close turnkey projects within budget and on time.
    • Develop strong relationships with clients, providing timely and accurate communications.
    • Deliver customized client training and education programs on Quality Management Systems and other industry topics.
    • Potentially serve as client adjunct quality staffing (Interim Quality Professional).

    Skills Requirements:

    • Bachelor's degree in Engineering, Regulatory and Compliance Management, Quality Engineering, or in a closely related / equivalent field.
    • Minimum five (5) years of experience monitoring and maintaining quality management systems to ensure compliance with government regulations within the medical device manufacturing industry. Experience to include:
      • Quality auditing experience to ensure compliance with ISO and FDA regulations.
      • Performing corrective and preventive action to address compliance issues.
      • Participating in FDA inspections.
    • Fluent (reading and speaking) in English and German.
    • Working knowledge and documented training in ISO 13485, FDA Quality System Regulation, and EU MDR.
    • Proven hands-on experience with document management, training, CAPA, electronic system development/validation, management review, risk management, and quality improvement initiatives.
    • Excellent communication and time management skills are required.
    • Lead Auditor certification is a plus.
    • Software experience is a plus, including knowledge of ISO 62304.
    • Usability experience is a plus, including knowledge of ISO 62366.
    • Electromechanical experience is a plus, including knowledge of ISO 60601.

     Please note the following:

    • Relocation is not available for this position as it is a remote role.
    • MEDIcept guarantees equal opportunities throughout the application process and compliance with local legislation in each country where MEDIcept Inc. operates. MEDIcept excludes any discriminatory factors, including but not limited to gender and age, ethnicity, religion or belief, sexual orientation, or disability.

    APPLY NOW

    Quality Systems Consultant (Combination Product SME)

    Classification: Full Time
    Location: Remote (must be US based)
    Travel: Yes, ~50% 

    Position Summary:

    The Quality Systems Consultant and Combination Product SME is a hands-on role supporting the Quality Management Systems department. This position includes supporting customer Quality requests and providing services related to current US and international regulations/guidelines/policies applicable to Combination Products. Must be a self-starter and a multi-tasker, as this position will work on multiple exciting client projects in tandem.

    Essential Duties and Responsibilities: (will be variable depending on the nature of the client projects to be undertaken)

    • Successfully develop and manage Quality Management Systems to meet FDA QSR 820, 210/211, Part 4, ISO 13485, EU MDR, MDSAP, and other applicable regulatory requirements.
    • Conduct / lead / assist clients with internal, supplier, ISO 13485, CE Mark, MDSAP audits, and FDA inspections.
    • Perform recidivist certification and due diligence audits.
    • Compliance strategy development, including enforcement action responses and/or corrective action plans (483s, warning letters, etc.), recall strategies.
    • Supplier Quality Management activities, including supplier audits and corrective action process (SCAR).
    • Deliver customized client training and education programs.
    • Corrective action strategy and development.
    • Preparation for FDA inspections and registrar or Notified Body assessments.
    • Identify client processes that may require improvement, correction, or additional contracted resources.
    • Successfully plan, manage, execute, and close turnkey projects within budget and on time.
    • Develop strong relationships with clients, providing timely and accurate communications.
    • Deliver customized client training and education programs on Quality Management Systems and other industry topics.
    • Potentially serve as client adjunct quality staffing (Interim Quality Professional).

    Skills and Qualifications:

    • Bachelor’s degree in Chemical, Biomedical, Mechanical, Material Science Engineering, or related field.
    • Minimum ten (10) years of experience monitoring and maintaining quality management systems to ensure compliance with government regulations within the medical device and life sciences industry, including drug product development experience.
    • Auditing and in-depth knowledge and experience working with 21 CFR Parts 4, 820, 210/211, 803, 806, ISO 13485, EU MDR, EU IVDR, and related International Requirements.
    • Experience with Post Market Safety Reporting, current Good Manufacturing Practice (cGMP) requirements for combination products; single-entity and co-packaged combination products.
    • Lead Auditor or Auditor certification a plus.
    • Proven hands-on experience with document management, training, CAPA, electronic system development/validation, management review, risk management, and quality improvement initiatives.
    • Excellent communication (oral, written, and verbal) and time management skills required.
    • Must be detail-oriented, thorough, and organized.
    • Excellent interpersonal skills with a customer service focus.
    • Ability to manage multiple projects simultaneously.
    • Must be self-motivated, able to work both independently and with a team.
    • Project Management experience a plus.

    Please note the following:

    • Applicants for this position must be legally authorized to work in the U.S.
    • We are not currently sponsoring work visas.
    • Relocation is not available for this position as it is a remote role.
    • We are an Equal Employment Opportunity employer. Drug free workplace.
    • We are following all state guidelines relative to safety precautions.

    APPLY NOW

    Financial Data Analyst

    Classification: Full Time
    Location: Office in Ashland, MA
    Travel (%): Less than 5%

    Position Summary:

    The Financial Data Analyst is responsible for maintaining/updating databases, analyzing data, and preparing reports to measure business metrics. A solid working knowledge of Excel is a requirement of the position. This position includes extensive work with data manipulation, spreadsheet analysis, problem solving, time management skills, and the ability to work independently. This position is best suited for an analytical person who likes working with numbers and who also understands how to interpret data relative P&L and other financial statements.

    Essential Duties and Responsibilities:

    • Develop and maintain advanced reporting and analytics to identify financial trends.
    • Assist with the development and management of company and department budget process.
    • Develop reports including gross margin, project profit, operating expenses, utilization, and revenue breakout.
    • Work with the accountants and bookkeeper to develop and compile data for annual and quarterly financial reports, state and federal tax filings, and bonus/commission calculations.
    • Reconcile transactions by comparing and correcting financial and sales data.
    • Use Salesforce, QuickBooks, Timesheets, and Excel to identify pipeline and revenue streams.
    • Assist in the establishment of policies and procedures that ensure adequacy of internal controls.
    • Ensure the consolidation, standardization and consistency of reporting and analytics across multiple business groups.
    • Develop financial strategies based on trending reports and present information to the leadership team.

    Skills and Qualifications:

    • Bachelor’s Degree in accounting or business finance.
    • Intermediate/advanced competency with Microsoft Office programs.
    • Minimum 3 years previous experience with accounting & data analytics.
    • Strong business acumen and project management experience.
    • Must be detail-oriented, thorough, and organized.
    • Strong analytical and problem-solving skills.
    • Excellent oral, written and verbal communication skills.
    • Excellent interpersonal skills with a customer service focus.
    • Ability to manage multiple projects simultaneously.
    • Must be self-motivated, able to work both independently and with a team.
    • Preferred experience with Salesforce.
    • Preferred experience with QuickBooks.

    Please note the following:

    • Must be legally authorized to work in the U.S.
    • We are not currently sponsoring work visas.
    • Relocation is not available for this position.
    • We are an Equal Employment Opportunity employer. Drug free workplace.
    • We are following all state guidelines relative to safety precautions.

    APPLY NOW

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