Quality Engineer

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

Consultant, Quality Engineer, Medical Devices

Our client, a growing medical device company, has engaged GForce Life Sciences to provide a 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 QE 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

• 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)