Medical Device Quality Engineer: Transfer & DMR Lead Remote

GForce Life Sciences; De Soto (MS); Hybrid; USD 60,000 - 80,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

401k

Job summary

GForce Life Sciences is seeking a Quality Engineer consultant for a medical devices transfer project. The role focuses on updating Device Master Records and ensuring process documentation aligns with new manufacturing site requirements.

The ideal candidate has 2+ years in medical device quality and PFMEA/risk management experience, collaborating with cross-functional teams to resolve gaps and ensure ISO 13485 compliance.

Qualifications

• 2+ years of experience in medical device quality, design quality, manufacturing quality, or related function.
• Direct experience in the medical device industry.
• Knowledge of DMRs and their required content.
• Understanding of PFMEA and risk management documentation.
• Familiarity with ISO 13485 and ISO 14971.
• Experience with quality documentation, manufacturing processes, or process transfers.

Responsibilities

• Review existing DMRs and identify documentation updates as manufacturing activities transfer.
• Update DMRs to reflect new processes, equipment, inspection, packaging, labeling, and site requirements.
• Review manufacturing process flows and ensure alignment with DMR requirements.
• Support PFMEA review and updates to reflect new facility processes.
• Evaluate risk management documentation for transferred processes.
• Ensure quality documentation remains consistent with ISO 13485 and ISO 14971.
• Identify gaps between existing documentation and new processes.
• Collaborate with Design Quality, Quality, Manufacturing, and other stakeholders to resolve discrepancies.
• Independently manage deliverables and communicate status.
• Apply transfer methodology across four product lines and multiple SKUs.

Skills

Medical device quality

Documentation control

PFMEA understanding

Risk management

DMR knowledge

Quality documentation

Education

Bachelor's degree in engineering or life sciences

Tools

ISO 13485

PFMEA

Risk assessment

Job description

GForce Life Sciences is seeking a Quality Engineer consultant for a medical devices transfer project. The role focuses on updating Device Master Records and ensuring process documentation aligns with new manufacturing site requirements.

The ideal candidate has 2+ years in medical device quality and PFMEA/risk management experience, collaborating with cross-functional teams to resolve gaps and ensure ISO 13485 compliance.