Quality Engineer - Medical Device

Responsibilities

• Perform detailed reviews of production line documentation, including: Process documentation, Work instructions, Training records, Validation documentation, Specifications and technical drawings.
• Identify documentation gaps, inconsistencies, and compliance risks.
• Partner cross-functionally with manufacturing, quality, and engineering teams to prioritize findings.
• Develop and execute remediation plans following gap assessments.
• Update and create SOPs, work instructions, and validation documentation as needed.
• Support transfer-to-manufacturing activities through structured risk mitigation.
• Ensure documentation aligns with regulatory and internal quality standards.
• Lead and/or support: Process FMEAs, Risk assessments tied to manufacturing transfer, Risk mitigation planning and documentation.
• Apply strong risk management principles to process validation and equipment qualification activities.
• Support process validation activities including: IQ/OQ/PQ execution, Equipment qualification documentation, Validation protocol review and approval.
• Ensure alignment between validation activities and risk management outputs.
• Review engineering drawings and specifications to confirm accuracy and alignment with production processes.
• Support sampling plan assessments: Evaluate sampling plans and statistical justifications, Determine appropriate sample sizes and rationale.
• Participate in production line startup and manufacturing support as needed.

Requirements

• 3–6+ years of experience in Quality Engineering (QE) and/or Manufacturing Engineering within Medical Devices.
• Strong experience leading or supporting: Process FMEAs, Risk management initiatives, Process validation activities.
• Experience reviewing and remediating manufacturing documentation.
• Working knowledge of equipment qualification (IQ/OQ/PQ).
• Ability to interpret engineering drawings and technical specifications.
• Desired Experience with instrumentation and electronics (strong plus for the Delaware site).
• Experience assessing sampling plans and statistical justifications (preferred but not required).
• Exposure to: Plastics manufacturing, Chemistry-based processes or test strip formulation, Experience supporting multi-site environments.