Principal Operations Quality Engineer – Medical Devices

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

Benefits offered by this job

Health, Dental, Vision insurance

401(k) plan

Paid time off

Job summary

Medtronic in North Haven, CT seeks a Principal Operations Quality Engineer to advance quality strategies for stapling product families in a manufacturing setting. This onsite role requires strong autonomy to drive complex initiatives and ensure regulatory compliance across quality systems.

You will collaborate with engineering and manufacturing to integrate quality into products and processes, perform root cause analyses, and mentor a team of quality professionals on cross-functional projects.

Qualifications

• Bachelor's degree and 7+ years of relevant quality or engineering experience in manufacturing.
• Experience in regulated manufacturing environments; strong knowledge of FDA QSR, ISO 13485, CAPA, change control, and risk management.

Responsibilities

• Lead development, implementation, and maintenance of quality standards, procedures, and protocols.
• Partner with Engineering and Manufacturing to integrate quality requirements into products and processes.
• Develop inspection, testing, and evaluation methods to verify product performance and process capability.
• Design or oversee inspection and testing systems for quality assessment.
• Conduct root cause investigations and risk assessments to drive corrective actions.
• Ensure quality documentation remains compliant with internal procedures and regulatory standards.
• Lead quality improvement initiatives and provide guidance on reliability and process controls.
• Mentor quality professionals and cross-functional teams on strategic projects.

Skills

Quality engineering

Regulated manufacturing

Root cause analysis

Statistical methods

CAPA

Change control

Process validation

Education

Bachelor's degree in engineering or related field

Master's degree in engineering or related field

Job description

Medtronic in North Haven, CT seeks a Principal Operations Quality Engineer to advance quality strategies for stapling product families in a manufacturing setting. This onsite role requires strong autonomy to drive complex initiatives and ensure regulatory compliance across quality systems.

You will collaborate with engineering and manufacturing to integrate quality into products and processes, perform root cause analyses, and mentor a team of quality professionals on cross-functional projects.