Hello,
I hope you're doing well.
My name is Mahalakshmi, and I’m reaching out from Intellectt Inc. regarding an exciting contract opportunity for a Senior Manufacturing Quality Engineer (Medical Device) based in Marlborough, MA, with one of our prestigious clients.
I would love to connect and discuss this opportunity in more detail. Please feel free to share your updated resume at mahalakshmi.n@intellectt.com OR +1 (732) 737 8381
Job Title: Senior Manufacturing Quality Engineer (Medical Device)
Location: Marlborough, MA
Job Summary
Seeking a hands-on Senior Manufacturing Quality Engineer with 5+ years of experience in medical device manufacturing to support production and process quality activities. The role involves process validation, quality documentation, risk management, and collaboration with Manufacturing, Validation, and Operations teams to ensure compliant and efficient manufacturing processes.
Key Responsibilities
- Provide daily quality engineering support for manufacturing operations.
- Support production and process quality activities.
- Lead and support Process Validation and TMV activities.
- Develop and maintain PFMEA, CAPA, CPQ, and CTQ documentation.
- Author and update protocols, reports, and quality documents.
- Collaborate with Manufacturing Engineering, Validation, and Operations teams.
- Troubleshoot quality issues and drive continuous improvement initiatives.
Required Qualifications
- 5+ years of Quality Engineering experience in medical device manufacturing.
- Strong background in production and process quality.
- Experience with electromechanical medical devices.
- Hands-on expertise in Process Validation, TMV, PFMEA, CAPA, and CPQ/CTQ.
- Strong technical writing and documentation skills.
- Ability to work on the manufacturing floor in a fast-paced environment.
Preferred Qualifications
- Experience with IVD (In Vitro Diagnostics) products.
- Familiarity with Agile PLM.
Ideal Candidate
Hands-on, execution-focused quality professional with strong problem-solving skills and the ability to work independently and cross-functionally in a regulated manufacturing environment.
Thanks & Regards,
Mahalakshmi
Junior Recruiter
Intellectt Inc
mahalakshmi.n@intellectt.com
Direct: +1 (732) 737 8381