Overview
Senior Quality Engineer Jobs in North Billerica, MA at TekPro
Title: Senior Quality Engineer
Company: TekPro
Location: North Billerica, MA
Overview:
A growing medical device company developing innovative fluidjet technology for sports medicine and spine procedures is seeking a quality professional to support and strengthen its Quality Management System and ensure compliance in a regulated environment.
Key Responsibilities:
- Support quality activities across design assurance, manufacturing, supplier quality, and audit readiness
- Contribute to risk management (FMEA, hazard analysis), design controls, and process validation (IQ/OQ/PQ)
- Partner cross-functionally to embed quality across product development and production
- Support FDA, Notified Body, and MDSAP audits, including responses and CAPA execution
- Analyze quality metrics and drive continuous improvement
- Oversee complaints, nonconformances, and post-market quality activities
Qualifications:
- Bachelor’s Degree in Engineering, Life Sciences, or related field
- 5–7 years of experience in medical device quality (QA/QE)
- Working knowledge of FDA QMSR (21 CFR 820), ISO 13485, and ISO 14971
