Quality Engineer - Medical Device

Role:
Quality Engineer – Medical Device

Location:

Delaware

Large scale Medical Device client facing a remediation project here on site in Delaware.

• We are seeking experienced Quality and/or Manufacturing Engineers to support a large-scale production documentation and remediation initiative at our client’s Newark, Delaware manufacturing site. These professionals will play a critical role in strengthening risk management practices, supporting transfer to manufacturing activities, and driving process validation and equipment qualification efforts.
• This engagement will begin with comprehensive documentation gap assessments across multiple production lines, followed by remediation and implementation activities to ensure manufacturing readiness and compliance.

• 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.
• Ability to read and interpret drawings is required (drafting not required).
• 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.

• 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.

• 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.

Best Regards, Satya Satish J | Technical Recruiter | IT Minds LLC |