Senior Quality Operations Leader: CAPA, PFMEA & NPI (Medical Devices)

Philips International; Tennessee; On-site; USD 134,000 - 213,000; Full time

Job summary

Philips is seeking a Senior Quality Operations Manager-Advanced Imaging to lead strategic process validation initiatives and drive improvements to product quality and manufacturing efficiency. You will manage the Quality team, oversee CAPA/non-conformance, PFMEA assessments, and ensure compliance with ISO 13485 and FDA regulations while supporting NPI and product transfers.

This role requires strong cross-functional collaboration with R&D, regulatory, and manufacturing, plus a Bachelor’s in

Qualifications

• Minimum 10+ years in FDA regulated (ISO 13485) medical device quality operations/manufacturing environments.
• Minimum 3+ years managing quality teams, budgeting, performance management, and engagement/retention.
• Experience managing CAPA, non-conformances, root cause analysis and preventive actions.
• Experience using quality, reliability and PMS insights to drive continuous improvement.

Responsibilities

• Lead CAPA processes and monitor effectiveness.
• Oversee PFMEA assessments and design change impact related to manufacturing.
• Drive supplier quality initiatives with cross-functional teams (R&D, regulatory, manufacturing).
• Maintain manufacturing quality systems and risk management.
• Lead NPI and product transfers to factory quality norms.

Skills

Quality operations

CAPA management

Non-conformance

PFMEA

Regulatory compliance

Data analytics

Education

Bachelor’s Degree in Quality/Engineering or related

Job description

Philips is seeking a Senior Quality Operations Manager-Advanced Imaging to lead strategic process validation initiatives and drive improvements to product quality and manufacturing efficiency. You will manage the Quality team, oversee CAPA/non-conformance, PFMEA assessments, and ensure compliance with ISO 13485 and FDA regulations while supporting NPI and product transfers.

This role requires strong cross-functional collaboration with R&D, regulatory, and manufacturing, plus a Bachelor’s in