Job Title: Document Control SpecialistJob 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, proo 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 (%20actalentaccommodation@actalentservices.com) for other accommodation options.
