What are the responsibilities and job description for the Quality Engineer - Medical Device position at IT Minds LLC?
Role: Quality Engineer – Medical Device
Location: Delaware
Largescale Medical Device client facing a remediation project here on site in Delaware.
What is the project the contractor will be working on?
Documentation Gap Analysis
Required:
Satya Satish J | Technical Recruiter | IT Minds LLC |
Location: Delaware
Largescale Medical Device client facing a remediation project here on site in Delaware.
What is the project the contractor will be working on?
- 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.
Documentation Gap Analysis
- 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.
Required:
- 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.
Satya Satish J | Technical Recruiter | IT Minds LLC |