Quality Engineer II – Medical Device NPD & Sustaining

Intellectt INC; Massachusetts; On-site; USD 62,000 - 69,000; Full time

Job summary

Intellectt INC. is seeking a Quality Engineer II (NPD/Sustaining) for an onsite role in Devens, MA. The position supports the development of a combination product and involves validation, QA documentation, and CAPA management.

The role requires experience in medical devices, IQ/OQ/PQ, and FMEAs, with duties spanning audits, design reviews, and process validation to ensure product quality and regulatory compliance.

Qualifications

• Medical Device/Combination Product experience required.
• Solid background in quality engineering and NPD.
• Experience with IQ/OQ/PQ and FMEAs.
• Ability to manage CAPAs and documentation.

Responsibilities

• Provide Quality Engineering and Validation support for the Program Managers on customer programs as required.
• Automated production line validation.
• Time out of refrigeration / time out of environment.
• Review daily rejects and implement or discuss action plans.
• Manage and investigate customer complaints.
• Manage CAPAs.
• Make appropriate changes in documentation as required.
• Create/Maintain FMEA's, AQPs, Deviations, Process flows, Validation Plans, IQ/OQ/PQ protocols, PPAP's as appropriate.
• Manage, analyze, and create reports for Process Capability studies, FAIR's, GR&R's, and other data before sending to customer.
• Create, modify, and maintain History Cards/ Control Plans /Inspection Work Instructions.
• Participate in internal and supplier audits.
• Participate in design reviews.

Skills

Quality Engineering

New Product Development

Sustainability

IQ/OQ/PQ

Tools

FMEA

Job description

Intellectt INC. is seeking a Quality Engineer II (NPD/Sustaining) for an onsite role in Devens, MA. The position supports the development of a combination product and involves validation, QA documentation, and CAPA management.

The role requires experience in medical devices, IQ/OQ/PQ, and FMEAs, with duties spanning audits, design reviews, and process validation to ensure product quality and regulatory compliance.