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Quality Systems Consultant

Job Title: Quality Systems Consultant
Classification: Full Time
Location: Remote
Travel (%): 50%

Company Summary:
MEDIcept is an international medical device, IVD, combination product and biotechnology compliance consulting firm. For over 25 years, our unique consulting practice has assisted thousands of companies of all sizes with cost- effective Regulatory, Quality, and Clinical services.

Please see www.medicept.com for more information.

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:
• 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 (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 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 and Qualifications:
• 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:
• 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.

Quality Systems Senior Consultant (ex-FDA)

Investigator experience a must.

Classification: Full Time
Location: Remote (must be US based)
Travel: ~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 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.

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Software Quality Engineer

Seniority Level: Mid-level
Industry: Medical Device / IVD / Biotech
Employment Type: Permanent
Location: Remote (must be US based)
Travel: Yes, candidate must have the desire and ability to travel

Company Summary:
MEDIcept is an international medical device, IVD, combination product and biotechnology compliance consulting firm. For over 25 years, our unique consulting practice has assisted thousands of companies of all sizes with cost- effective Regulatory, Quality, and Clinical services.

Please see www.medicept.com for more information.

Position Summary:
Technical, hands-on role to support our rapidly expanding Quality team. A self-starter and a multi-tasker, this individual will work on multiple exciting projects in tandem, with limited supervision. While software quality engineering 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:
• Work with clients to develop IEC 62304, ISO 13485, 21 CFR 820, 60601 compliant documentation (all product/software classifications)
• Design History File audits for compliance to IEC 62304, 60601, 21 CFR 820, ISO 13485.
• Serve as client Software Quality Engineering function including assistance with software development documents (including cybersecurity), risk management files, and 60601 deliverables.
• Must be able to assist clients with risk-based decisions using critical thinking
• Leading and mentoring Agile software teams:
o Development Lifecycle Planning
o Requirement Development
o Hazard Analysis
o Cybersecurity Threat Modeling
o Anomaly Analysis
o Verification documentation methods
o Automated testing
• Cybersecurity implementation development, including post-market Vulnerability Monitoring.
• 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 and Qualifications:
• Bachelor's degree in Engineering, Computer Science, or in a closely related / equivalent field.
• Minimum five years of experience in quality engineering including software quality environment within the Medical Device industry.
• Proven hands-on experience with implementation of IEC 62304, ISO 13485, and ISO 14971.
• Knowledge of AI/ML, Bluetooth, IoT, and mobile devices.
• Working knowledge of Part 11, IEC 60601, Human Factors, EU MDR, and medical device cybersecurity (e.g., UL 2900, AAMI TIR57 and TIR97, ISO 27001, IEC 62443, NIST SP 800-53, NIST 800-30, SOC Type 2).
• 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:
• 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.

Quality Systems Generalist

Job Title: Quality Systems Generalist
Classification: Full Time
Location: Remote
Travel: 50%

Company Summary:
MEDIcept is an international medical device, IVD, combination product and biotechnology compliance consulting firm. For over 25 years, our unique consulting practice has assisted thousands of companies of all sizes with cost- effective Regulatory, Quality, and Clinical services.

Please see www.medicept.com for more information.

Position Summary: (this is just a high-level overview of the role as a whole) Example: The Quality Systems Generalist 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:
• Assist with development and management of 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.
• Manage the day-to-day administration of documents to support releases and changes in compliance with client’s policies and procedures (e.g., document and engineering change control).
• Supports review, update, filing and distribution of controlled documents, including standard operating procedures and technical documents.
• Create trend reports for quality systems (e.g., CAPA, Change Control, Training).
• Perform recidivist certification and due diligence audits.
• Supplier Quality Management activities, including supplier audits and corrective action process (SCAR).
• Assist with 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 and Qualifications:
• Bachelor’s degree in Engineering, Regulatory and Compliance Management, Quality Engineering, or in a closely related / equivalent field.
• Minimum three (3) years of experience monitoring and maintaining quality management systems to ensure compliance with government regulations within the medical device, life sciences industry, PLM (e.g., Arena) or eQMS (e.g., QT9) experience a plus.
• Auditing and in-depth knowledge and experience working with 21 CFR Parts 820, 803, 806 and ISO 13485, ISO 9001, and related International Requirements preferred, EU MDR a plus.
• Lead Auditor or Auditor certification a plus.
• Strong technical computer skills with proficiency using various computer programs and web-based applications, including Microsoft Word, Excel, PowerPoint, One Drive, SharePoint, Dropbox, Box, Egnyte, etc.
• 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:
• 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.

Controller

Job Title: Controller

Classification: Full time

Location: Office in Ashland, MA

Travel (%): <5%

Company Summary:

MEDIcept is an international medical device, IVD, combination product and biotechnology compliance consulting firm. For over 27 years, our unique consulting practice has assisted thousands of companies of all sizes with cost- effective Regulatory, Quality, and Clinical services.

Please see www.medicept.com for more information.

Position Summary:  The Controller is responsible for having a finger on the pulse of the financial health of the organization. This position requires preparing timely financial reports, analyzing data, and measuring business metrics. A solid working knowledge of Excel and QuickBooks is a requirement of the position to work with accrual accounting and spreadsheet analysis. This position is best suited for an analytical person who understands how to interpret data relative P&L and other financial statements.

Essential Duties and Responsibilities:

Lead all accounting and financial operations to include cash flow management; budget management; financial KPI management; oversee payroll; accounts receivable and payable; short/long term financial health; financial risk and tax strategy; financial trending and projection. Specifically:

  • Lead FP&A (Financial Planning and Analysis) with Executive Committee to develop long-range financial projections
  • Develop, measure, and communicate key financial performance metrics of our business; evaluate our financial performance and productivity against industry benchmarks; innovate and work with Executive Committee to develop strategies to close any gaps and improve performance
  • Manage the communication of key client project financial information to Executive Committee
  • Establish and maintain detailed departmental budgets and KPIs working closely with Department leaders
  • Be responsible for tax strategy, projections, and filings with our tax accountants; assist our tax accountants on any related matters
  • Own and manage internal self-audits and external audits with outside auditors
  • Maintain compliance with all federal and state laws
  • Use Salesforce, QuickBooks, Timesheets, and Excel to identify pipeline and revenue streams.

Skills and Qualifications:

  • A BS or MS in Finance and/or Accounting or MBA
  • A minimum of 5 years of working experience leading the financial and operational functions
  • 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:

  • This is a hybrid position with a minimum of 3 days in office, Ashland, MA
  • 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.
Office Manager

Job Title: Office Manager

Classification: Full Time

Location: Ashland, MA

Company Summary:

MEDIcept is an international medical device, IVD, combination product and biotechnology compliance consulting firm. For over 25 years, our unique consulting practice has assisted thousands of companies of all sizes with cost-effective Regulatory, Quality, and Clinical Services.

Please see www.medicept.com for more information.

Position Summary:

Our company is seeking a reliable, organized, and detail-oriented Office Manager to oversee the daily operations of our office. The Office Manager will be responsible for ensuring that office operations and procedures are organized, managing administrative tasks, managing with timesheets and accounts receivable, assisting with HR functions, and supporting the President with daily responsibilities.

Essential Duties and Responsibilities:

  • Process and track invoices and expenses in QuickBooks, ensuring accuracy and timely payments.
  • Maintain timesheet data for employees and contractors.
  • Assists in the collection of payments from clients.
  • Assist with the onboarding of new staff members, including coordinating the necessary equipment and programs needed for their jobs.
  • Provide administrative support for executive-level staff including scheduling appointments and meetings, travel coordination, and calendar management.
  • Maintain employee files and ensure compliance with HR policies and procedures.
  • Manage day-to-day office operations, including answering phones, greeting visitors, and handling incoming and outgoing mail and packages.
  • Assist in planning and execution of company events.
  • Manage office inventory, office supplies, equipment, and furniture, as needed.
  • Ensure the office environment is clean, safe, and welcoming for staff and visitors.

Skills and Qualifications:

  • High school diploma or equivalent required.
  • Associate or Bachelor’s degree in Business Administration or related field preferred.
  • At least 2-3 years of experience in an administrative or office management role.
  • Proficient in Microsoft Office, Google Suite, and QuickBooks.
  • Familiarity with basic accounting and HR principles.
  • Excellent organizational and time management skills.
  • Strong communication and interpersonal skills.
  • Ability to multitask and prioritize effectively in a fast-paced environment.
  • High level of attention to detail and accuracy and ability to multi-task in a fast-paced environment.

Please note the following:

  • This position is not a remote role. You must be able to commute to the office in Ashland, Massachusetts on a daily basis.
  • 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.

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