Senior Quality Ops Leader – Advanced Imaging

Philips International; Bedford (MA); 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 in Bedford, MA seeks a Senior Quality Operations Manager to lead strategic validation initiatives, drive continuous improvement, and uphold ISO 13485 and FDA requirements across quality operations. You will manage a quality team, own CAPA and NC/QN processes, coordinate PFMEA impact assessments, and oversee transfer/NPIs while ensuring supplier quality and regulatory compliance.

The role requires 10+ years in regulated environments, a Bachelor's in Quality/Engineering, and optional

Qualifications

• Minimum 10+ years in FDA-regulated (ISO 13485) medical device quality operations/manufacturing environments.
• Minimum 3+ years managing quality teams (budgeting, workforce planning, performance management).
• Experience managing CAPA, non-conformances with root-cause analysis and preventive actions.
• Strong data analytics and use of PMS insights to drive continuous improvement.
• Experience with PFMEA assessments, design changes, and NPI/product transfers.
• Ability to collaborate across R&D, manufacturing, regulatory affairs and suppliers.
• Environmental control programs and sterilization validation experience.

Responsibilities

• Oversee strategic process validation initiatives and drive improvements to quality and efficiency.
• Lead CAPA, NC/QN processes; investigate root causes and implement corrective actions.
• Manage quality team talent, hiring, performance, and development.
• Ensure compliance with FDA and ISO 13485; manage QMS and risk (ISO 14971).
• Coordinate PFMEA assessments and changes tied to design transfers and NPIs.
• Collaborate with R&D, manufacturing, and regulatory teams to address gaps and uphold standards.

Skills

Quality operations

CAPA management

Non-conformances handling

PFMEA

ISO 13485

FDA regulated

Data analytics

Team management

Cross-functional collaboration

Environmental controls

Education

Bachelor’s Degree in Quality, Engineering or related

ASQ-CQE certification

ISO Lead Auditor certification

Job description

Philips in Bedford, MA seeks a Senior Quality Operations Manager to lead strategic validation initiatives, drive continuous improvement, and uphold ISO 13485 and FDA requirements across quality operations. You will manage a quality team, own CAPA and NC/QN processes, coordinate PFMEA impact assessments, and oversee transfer/NPIs while ensuring supplier quality and regulatory compliance.

The role requires 10+ years in regulated environments, a Bachelor's in Quality/Engineering, and optional