Lead Operations Quality Engineer, Medical Devices

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

Job summary

Medtronic plc, based in North Haven, CT, seeks a Principal Operations Quality Engineer to advance quality strategies and support manufacturing and engineering operations in the Advanced Surgical Instruments family. This onsite role leads complex quality initiatives, guides teams, and ensures compliance with FDA and ISO requirements.

The position emphasizes technical autonomy, cross-functional influence, and a strong focus on product reliability and process controls within a regulated

Qualifications

• Bachelor's degree and 7+ years of relevant quality, manufacturing, or engineering experience, OR Master's degree and 5+ years of relevant experience, OR PhD and 3+ years of relevant experience.
• Experience supporting quality engineering activities within a regulated manufacturing environment.

Responsibilities

• Lead development, implementation, and maintenance of quality standards, procedures, and protocols supporting manufacturing operations and product quality.
• Partner with Engineering and Manufacturing teams to ensure quality requirements are integrated into products, processes, and operational controls.
• Develop and implement inspection, testing, and evaluation methods to verify product performance, process capability, and equipment accuracy.
• Design, specify, or oversee inspection and testing systems used to assess product quality and manufacturing effectiveness.
• Conduct root cause investigations, statistical analyses, and risk assessments to identify quality issues and drive corrective and preventive actions.
• Ensure quality documentation, records, and processes remain compliant with internal procedures, regulatory requirements, and applicable standards.
• Lead complex quality improvement initiatives and provide technical guidance on product reliability, process controls, and quality system enhancements.
• Mentor and provide direction to quality professionals and cross-functional teams on strategic projects.

Skills

Quality engineering

Manufacturing quality

Regulatory understanding

Education

Bachelor's degree

Master's degree

PhD

Job description

Medtronic plc, based in North Haven, CT, seeks a Principal Operations Quality Engineer to advance quality strategies and support manufacturing and engineering operations in the Advanced Surgical Instruments family. This onsite role leads complex quality initiatives, guides teams, and ensures compliance with FDA and ISO requirements.

The position emphasizes technical autonomy, cross-functional influence, and a strong focus on product reliability and process controls within a regulated