Senior/Principal Quality Systems Consultant

NAMSA pioneered the industry and was the first independent company in the world to focus solely on medical device materials for safety. NAMSA started testing medical devices before the U.S. Food and Drug Administration started regulating such products in 1976.

We are shaping the industry. NAMSA has been a key contributor to the development of the test methods that govern our industry. We have become the industry’s premier provider. We provide support for clients during every step of the product development lifecycle and beyond.

Come and work for an organization with the:

Vision to inspire innovative MedTech solutions that advance global healthcare, improve patient lives and accelerate Client success and the

Mission to deliver best-in-class global MedTech development solutions through our people, expertise and technology by adhering to our core

Values:

• Act with integrity in everything we do.
• Provide best-in-class customer experiences.
• Develop superior talent and deliver expertise.
• Respond with agility and provide timely results.
• Embrace collaboration, diverse perspectives and ideas.

Job Description:

• Participate in meetings with prospective clients.

• Provide scope of project and relevant information to support the creation of proposals.

• Identify opportunities to bring in new projects/clients.

• Offer opportunities to clients for expansion of MRO services to be provided by NAMSA.

• Speak at conferences, webinars, or other marketing venues.

• Demonstrated knowledge of ISO 13485, Good Manufacturing Practices (FDA QSR), EU Medical Device Directives

• Perform QS gap analysis and write clear concise report

• Assist clients on addressing QS gaps, including CAPA, complaints, Design Controls, Risk Management, Document Controls, etc.

• Lead auditor for client and supplier audits; pre-ISO, ISO 13485, ISO 9001, mock QSR inspection

• Assist clients with ISO audits and FDA inspections

• Develop and implement Manufacturing Process and Equipment Validations

• Manage at least 3 client projects concurrently

• Develop estimates for audits and gap analyses

• Implement a Document and Data control system both virtual and on-site

• Support client on-site with Quality Engineering/Quality Management

• Evaluate and interpret standards related to product, quality system/design control and manufacturing for client; perform standard evaluation

• Auditor Certification is preferred, e.g. ASQ CQA or ASQ CBA

• Plan and implement full ISO 13485/QSR Quality Systems as well as systems for small and virtual companies

• Identify level of QSR implementation a project/client requires by understanding practical implications of size and complexity

• Act as a Quality Systems expert during ISO audits and FDA inspections

• Develop estimates for process/equipment validations, design history files, tech files and QS implementation

• Act as a lead during ISO audits and FDA inspections

• Defend corporate quality rationale to an auditor or regulatory agency personnel (i.e., 483 finding(s) for Device/Biologic and/or Combination Products

• Develop and implement strategies to assist clients with major audit deficiencies, including development of FDA 483 responses

• Act as a Quality System Manager/Director on-site at a client

Qualifications & Technical Competencies:

Principal Duties and Responsibilities

Quality Systems Consultant & Senior Quality Systems Consultant

• Participate in meetings with prospective clients.
• Provide the scope of the project and relevant information to support the creation of proposals.
• Identify opportunities to bring in new projects/clients.
• Offer opportunities to clients for expansion of MRO services to be provided by NAMSA.

Principal Quality Systems Consultant

In addition to the items listed above:

• Speak at conferences, webinars, or other marketing venues.
• Role-Specific Duties and Responsibilities
• Demonstrated knowledge of ISO 13485, Good Manufacturing Practices (FDA QSR), EU Medical Device Directives
• Perform QS gap analysis and write clear concise report
• Assist clients in addressing QS gaps, including CAPA, complaints, Design Controls, Risk Management, Document Controls, etc.
• Lead auditor for client and supplier audits; pre-ISO, ISO 13485, ISO 9001, mock QSR inspection
• Assist clients with ISO audits and FDA inspections
• Develop and implement Manufacturing Process and Equipment Validations
• Manage at least 3 client projects concurrently
• Develop estimates for audits and gap analyses
• Implement a Document and Data control system, both virtual and on-site
• Support client on-site with Quality Engineering/Quality Management
• Evaluate and interpret standards related to the product, quality system/design control, and manufacturing for the client; perform a standard evaluation
• Auditor Certification is preferred, e.g. ASQ CQA or ASQ CBA

Senior Quality Systems Consultant

• In addition to the items listed above:
• Plan and implement full ISO 13485/QSR Quality Systems as well as systems for small and virtual companies
• Identify the level of QSR implementation a project/client requires by understanding the practical implications of size and complexity
• Act as a Quality Systems expert during ISO audits and FDA inspections
• Develop estimates for process/equipment validations, design history files, tech files, and QS implementation

Principal Quality Systems Consultant

In addition to the items listed above:

• Act as a lead during ISO audits and FDA inspections
• Defend corporate quality rationale to an auditor or regulatory agency personnel (i.e., 483 finding(s) for Device/Biologic and/or Combination Products
• Develop and implement strategies to assist clients with major audit deficiencies, including the development of FDA 483 responses
• Act as a Quality System Manager/Director on-site at a client

Qualifications and Skills

• Qualifications

Quality Systems Consultant

Requires a minimum of

• Bachelor’s degree or equivalent experience in a related field, with a minimum of 5 years of relevant experience; and
• Project management experience.
• Fluency in English and local language, if different, required.

Senior Quality Systems Consultant

Requires a minimum of

• Bachelor’s degree or equivalent experience in a related field, with a minimum of 8 years of relevant experience; and
• Project management experience.
• Fluency in English and local language, if different, required.

Principal Quality Systems Consultant

Requires a minimum of

• Bachelor’s degree or equivalent experience in a related field, with a minimum of 10 years of relevant experience; and
• Project management experience.
• Fluency in English and local language, if different, required.

Senior Principal Quality Systems Consultant

Requires a minimum of

• Bachelor’s degree or equivalent experience in a related field, with a minimum of 12 years of relevant experience; and
• Project management experience.
• Fluency in English and local language, if different, required.

Technical Competencies

• Knowledge and experience with Quality System standards and regulations.
• Ability to assess/audit compliance of Quality Systems to applicable standards and regulations.
• Ability to develop Quality Systems that are compliant with applicable standards and regulations.