Description:

RESPONSIBILITIES:

• Provide strategic direction for design change teams in terms of quality functions including design quality, manufacturing quality, process validation, supplier quality, post-market quality and risk management.

• Ensure proactive compliance to all applicable internal, domestic, and international regulations including US 21 CFR 820 (QSR), ISO 19471:2019 and ISO 13485:2016.

• Ensure compliant and complete product documentation, inclusive of DHFs, with particular focus on design controls, risk management and document controls.

• Lead extended Quality teams for design change projects.

• Review and approve design and development documentation including Design Development plans, Design Change plans, User Needs, Design Input and Design Output documents, Design Verification Protocols and Reports, Design Validation Protocols and Reports, and System Risk Assessment documentation.

• May review and approve engineering drawings, specifications, procedures, engineering changes, and manufacturing work instructions, etc.

• Assures that products subjected to design changes are successfully transferred into the supply chain including manufacturing and service environments.

• Participates in Design Reviews and develop, approve, and review associated documentation.

• Responsible for Design History File (DHF) completeness and maintenance.

• Utilize problem solving techniques ad take a broad perspective to identify innovative solutions.

• Interact frequently with other functional areas and operating entities which requires specialized depth and/or breadth of expertise.

Skills & Qualifications:

MUST:

-Must have 2+ years of experience in Medical device industry

-Knowledge working with DHF, RMF, PMS ( Post Market Surveillance)

-Engineering Degree

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent

• Maintaining an inclusive environment through persistent self-reflection

• Building a culture of care, engagement, and recognition with clear outcomes

• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.