Medical Device Design Quality Engineer – Transfer & Documentation

GForce Life Sciences; Memphis (TN); Hybrid; USD 55,000 - 83,000; Part time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

401k

Job summary

GForce Life Sciences partners with a growing medical device company to hire a Consultant, Design Quality Engineer to support manufacturing and product transfers. The role involves reviewing DMRs and ensuring documentation mirrors new site processes, including final and packaging inspections, labeling, and related activities.

Ideal candidate has about 2+ years in medical device quality, with knowledge of PFMEAs, ISO 13485/14971, and risk management.

Qualifications

• Approximately 2+ years of experience in medical device quality, design quality, manufacturing quality, or a closely related function.
• Direct experience in the medical device industry is required.
• Working knowledge of Device Master Records (DMRs) and their required content.
• Understanding of PFMEAs and risk management documentation.
• Knowledge of ISO 13485 and ISO 14971.
• Experience with quality documentation, manufacturing processes, or process transfers.

Responsibilities

• Review existing Device Master Records (DMRs) and identify documentation requiring updates as manufacturing activities transition.
• Update DMRs to reflect new manufacturing processes, equipment, inspection activities, packaging, labeling, and site-specific requirements.
• Review manufacturing process flows and ensure alignment with DMR requirements and quality documentation.
• Support PFMEA reviews to ensure risks and controls reflect the new facility.
• Evaluate risk management documentation associated with transferred processes.
• Ensure quality documentation remains consistent with ISO 13485 and ISO 14971 requirements.
• Identify gaps between existing docs and implemented processes.
• Collaborate with Design Quality, Quality, Manufacturing and others to resolve discrepancies.
• Independently manage deliverables and communicate status and issues.
• Apply transfer methodology across four product lines and multiple SKUs.

Skills

Medical device quality

Design quality

Manufacturing quality

Job description

GForce Life Sciences partners with a growing medical device company to hire a Consultant, Design Quality Engineer to support manufacturing and product transfers. The role involves reviewing DMRs and ensuring documentation mirrors new site processes, including final and packaging inspections, labeling, and related activities.

Ideal candidate has about 2+ years in medical device quality, with knowledge of PFMEAs, ISO 13485/14971, and risk management.