Senior Operations Quality Engineer - Medical Devices

Medtronic; North Haven (CT); On-site; USD 121,000 - 181,000; Full time

Benefits offered by this job

Health, Dental, Vision insurance

401(k) with match

Tuition assistance

Paid time off

Job summary

Medtronic in North Haven, CT, is seeking a Principal Operations Quality Engineer to lead quality strategies and collaborate with engineering, manufacturing, and cross‑functional teams on product reliability and process quality. This onsite role emphasizes regulatory compliance and continuous improvement in a fast‑paced manufacturing environment.

The position requires substantial experience in quality engineering within regulated settings, with a focus on leading investigations, CAPA, and quality

Qualifications

• Bachelor's degree in engineering or related field with 7+ years of quality/manufacturing/engineering experience, or master's with 5+ years, or PhD with 3+ years.
• Experience in a regulated manufacturing environment supporting quality engineering activities.

Responsibilities

• Lead development and maintenance of quality standards and protocols.
• Partner with Engineering and Manufacturing to integrate quality into products.
• Develop inspection and testing methods to verify performance.
• Design and oversee inspection systems for quality.
• Conduct root cause analyses and risk assessments for quality issues.
• Ensure quality documents and processes comply with standards.
• Lead complex quality improvement initiatives and guide teams.
• Mentor quality professionals on strategic projects.

Skills

Quality engineering

Manufacturing experience

Regulatory compliance

Root cause analysis

Cross-functional collaboration

Leadership

Education

Bachelor's degree in engineering or related field

Master's degree in engineering

PhD in engineering

Job description

Medtronic in North Haven, CT, is seeking a Principal Operations Quality Engineer to lead quality strategies and collaborate with engineering, manufacturing, and cross‑functional teams on product reliability and process quality. This onsite role emphasizes regulatory compliance and continuous improvement in a fast‑paced manufacturing environment.

The position requires substantial experience in quality engineering within regulated settings, with a focus on leading investigations, CAPA, and quality