Design Quality Engineer

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

Consultant, Design Quality Engineer, Medical Devices

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)