Description:

Quality Engineer will support manufacturing operations such as process validations and line transfer projects. They will lead the process for closing out CAPAs and NCRs within a timely manner.

Skills:

NCR, Vendor Procurement, Change Notification, IQ/OQ/PQ, Project Management, Technical Writing, Regulatory Submission, CAPA, Document Change Orders, Line Transfer, Medical Device, 13485, 820, CAPM, PMI

Additional Skills & Qualifications:

Preference for candidates from small companies or startups, but open to those from larger companies if they have diverse experience.Medical device experience is strongly preferred.Open to candidates from automotive and aerospace industries due to their regulated nature.Project management skills are essential, though formal certification (CAPM, PMI) is not required.Strong background in technical writing for regulatory submissions.Top three important skills: cross-functional team work, project management knowledge, and technical writing.

Experience Level:

Intermediate Level

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 for other accommodation options.