Senior Imaging Quality Operations Leader

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

Benefits offered by this job

Generous PTO

401k match

HSA with company contribution

Stock purchase plan

Education reimbursement

Job summary

Philips is seeking a Senior Quality Operations Manager for Advanced Imaging in Bedford, MA. You will oversee strategic process validation, CAPA/nonconformance, PFMEA assessments, and drive improvements to product quality and manufacturing efficiency while ensuring regulatory compliance.

You will lead quality teams, manage CAPA programs, supplier quality, and maintain NPI and product transfer processes, partnering with R&D, manufacturing and regulatory affairs to sustain top-tier quality across

Qualifications

• 10+ years in FDA-regulated (ISO 13485) medical device quality operations/manufacturing.
• 3+ years leading quality teams including budgeting and workforce planning.
• Proven CAPA, non-conformance, root-cause analysis and corrective action experience.
• Experience with PFMEA and assessing impact of design changes.
• Bachelor’s degree in Quality, Engineering or related; ASQ-CQE / ISO Lead Auditor is desirable.

Responsibilities

• Oversee CAPA/NC/QN processes and CAPA effectiveness.
• Lead process validation activities, PFMEA assessments and design transfer support.
• Drive supplier quality initiatives and cross-functional collaboration with R&D, manufacturing and regulatory affairs.

Skills

Quality operations

CAPA

PFMEA

Team leadership

Regulatory compliance

Education

Bachelor’s Degree in Quality or Engineering

ASQ-CQE / ISO Lead Auditor (desired)

Job description

Philips is seeking a Senior Quality Operations Manager for Advanced Imaging in Bedford, MA. You will oversee strategic process validation, CAPA/nonconformance, PFMEA assessments, and drive improvements to product quality and manufacturing efficiency while ensuring regulatory compliance.

You will lead quality teams, manage CAPA programs, supplier quality, and maintain NPI and product transfer processes, partnering with R&D, manufacturing and regulatory affairs to sustain top-tier quality across