Quality Engineer – Medical Device – IT Minds LLC

Job Description

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?

• 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.

Quality Engineer (Remediation)

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.

Remediation & Implementation

• 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.

Risk Management & FMEA

• 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.

Process Validation & Equipment Qualification

• 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.

Technical Review & Support

• 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.

Skills

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.

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.

Best Regards,

Satya Satish J | Technical Recruiter | IT Minds LLC |