Design Quality Engineer

GForce Life Sciences; Memphis (TN); On-site; USD 120,000 - 145,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

401k

Job summary

GForce Life Sciences is seeking a Consultant, Design Quality Engineer to support a critical manufacturing and product transfer initiative for a medical devices client. The role focuses on updating Device Master Records and related quality documentation to reflect site-specific processes, including inspection, packaging and labeling.

Ideal candidates have about 2+ years in medical device quality, with direct industry experience and knowledge of PFMEAs, DMRs, ISO 13485 and ISO 14971.

Qualifications

• 2+ years in medical device quality, design quality or manufacturing quality.
• Direct medical device industry experience.
• Knowledge of Device Master Records (DMRs) and content.
• Understanding of manufacturing process flows, PFMEAs, and risk docs.
• Familiarity with ISO 13485 and ISO 14971.
• Experience with quality docs, processes or transfers.

Responsibilities

• Review DMRs and update documentation for transfer.
• Update DMRs to reflect new processes, equipment, inspection, packaging, and labeling.
• Review process flows to align with DMRs.
• Support PFMEA review and updates for new facility.
• Evaluate risk management docs for transferred processes.
• Ensure docs meet ISO 13485/14971.
• Identify gaps between docs and implemented processes.
• Collaborate with cross-functional teams to resolve discrepancies.
• Manage deliverables and communicate status.
• Apply transfer methodology across product lines and SKUs.

Skills

Medical device quality experience

PFMEA

Documentation review

Cross-functional collaboration

Tools

ISO 13485 knowledge

ISO 14971 knowledge

Job description

Consultant, Design Quality Engineer, Medical Devices

Summary

Our client, a growing medical device company, has engaged GForce Life Sciences to provide a Design Quality Engineer to support a critical manufacturing and product transfer initiative. This individual will support the transfer of product designs and manufacturing/processing activities.

The DQE will be responsible for reviewing and updating Device Master Records (DMRs) and related quality documentation to ensure that documentation accurately reflects the processes being implemented at the new manufacturing site. Key areas include final inspection, packaging inspection, labeling, and other applicable processing activities. This is an ideal opportunity for an early-career medical device quality professional who has approximately 2+ years of relevant experience and can work independently with minimal day-to-day direction.

Responsibilities

• Review existing Device Master Records (DMRs) and identify documentation requiring updates as manufacturing activities transition.
• Update DMRs to accurately reflect the new manufacturing processes, equipment, inspection activities, packaging, labeling, and site-specific requirements.
• Review manufacturing process flows and ensure they align with applicable DMR requirements and quality documentation.
• Support the review and update of Process Failure Mode and Effects Analyses (PFMEAs) to ensure identified risks and controls accurately reflect the processes at the new facility.
• Evaluate applicable risk management documentation associated with transferred manufacturing processes.
• Ensure quality documentation remains consistent with applicable ISO 13485 and ISO 14971 requirements.
• Identify gaps or inconsistencies between existing documentation and the processes being implemented.
• Collaborate with Design Quality, Quality, Manufacturing, and other cross-functional stakeholders to resolve documentation and process discrepancies.
• Independently manage assigned deliverables, identify next steps, and proactively communicate project status and potential issues.
• Apply the established transfer methodology across four product lines and multiple SKUs.

Requirements

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

Terms & Start

• 6 month contract
• Start ASAP
• Prefer to be based out of Olive Branch, MS but remote is ok
• 5 days onsite with flexibility
• Benefits available (Medical, Dental, Vision, 401k)