Job Title: Document Control Specialist

Job Description

- Review documentation for new, revised, custom, and foreign products for complete official documentation records required to manufacture medical products

- In coordination with the Engineering team, prepare new and revised product DMR and MM configurations and documentation using the required PLM, ERP, and UDI database systems (Grand Ave)

- Manage ECOs, Production ECOs/ECRs, Sustaining Change ECOs/ECRs, DMR review, SAP/Pre-Checks, and SAP review

- Review DMR-related documents and attachment files submitted for creation or changes

- Standardize format, proofread for errors or clarity, and verify configuration

- Submit documents for approval signatures, coordinate corrections and changes by approvers, and issue documentation package(s)

- Update appropriate personnel on open projects as required

- Assist and communicate with engineering, marketing, and regulatory bodies in preparing new or revised product documentation packages

- Assist in formalizing documentation, as required

- Follow regulatory requirements, internal procedures, and most recent guidance available in Design Control, DMR, change management, and inspection

- Maintain quality system controls to ensure state of compliance

- Support incoming inspection (quality focused), regulatory inspections, and audits as needed

Hard Skills

• 2 years of experience within Medical Device
• 2 years of experience in applicable roles
• Document Control
• Quality Control (within Med Dev)
• Incoming Inspection

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.

Salary : $25 - $30