Operations Quality Engineer II – Med Devices

BioCT; North Haven (CT); On-site; USD 79,000 - 119,000; Full time

Benefits offered by this job

Health, dental & vision insurance

401(k) with company match

Tuition assistance

Job summary

Medtronic in North Haven, Connecticut, is seeking an Operations Quality Engineer II to support manufacturing operations within Advanced Surgical Instruments, focusing on Stapling product families. This role requires onsite presence five days a week and offers opportunities to drive product quality and process improvements.

You will lead complex investigations, CAPAs, and cross‑functional collaboration with Engineering, Manufacturing, and quality teams to ensure compliance, reliability, and

Qualifications

• Bachelor's degree with 2+ years of quality, manufacturing, or engineering experience, or Master's with 0 years.
• Experience in medical device or regulated manufacturing environments a plus.
• Knowledge of QSR/ISO 13485 or equivalent quality standards desirable.

Responsibilities

• Support quality engineering initiatives to improve product quality and manufacturing performance.
• Partner with manufacturing and engineering to maintain and enhance quality standards and control methods.
• Develop and implement inspection, testing, validation, and monitoring strategies for products and processes.
• Analyze quality, process, and production data to identify trends and drive corrective actions.
• Lead root cause investigations and verify effectiveness of corrective actions.
• Support regulatory audits and quality system readiness.

Skills

Quality systems

CAPA & investigations

Cross-functional collaboration

Education

Bachelor's degree with 2+ years quality/mfg/eng experience OR Master's with 0 years

Job description

Medtronic in North Haven, Connecticut, is seeking an Operations Quality Engineer II to support manufacturing operations within Advanced Surgical Instruments, focusing on Stapling product families. This role requires onsite presence five days a week and offers opportunities to drive product quality and process improvements.

You will lead complex investigations, CAPAs, and cross‑functional collaboration with Engineering, Manufacturing, and quality teams to ensure compliance, reliability, and