Senior Quality Operations Leader - Advanced Imaging

Philips; Bedford (MA); On-site; USD 134,000 - 213,000; Full time

Benefits offered by this job

401k match

PTO

HSA

Stock purchase plan

Education reimbursement

Job summary

Philips Bedford, MA seeks a Senior Quality Operations Manager to oversee strategic validation initiatives, drive improvements to product quality and manufacturing efficiency, and ensure compliance with FDA regulations.

You will lead CAPA, NC and QN processes, manage a quality team, collaborate with R&D, manufacturing, and regulatory affairs, and support NPI and product transfers to meet quality standards. Office-based role with on-site requirements and possible travel as needed.

Qualifications

• Minimum 10+ years in FDA-regulated medical device quality operations.
• Minimum 3+ years leading quality teams, budgeting, and performance management.
• Deep expertise in CAPA, non-conformances, root cause analysis and corrective actions.
• Experience with PFMEA, Change/Risk Management (ISO 14971).
• Experience using quality analytics and PMS insights to drive improvements.

Responsibilities

• Oversee strategic process validation initiatives and continuous improvements.
• Lead CAPA and NC/QN processes and monitor effectiveness.
• Drive PFMEA assessments related to design changes and transfers.
• Ensure validation activities and NPI/product transfers meet quality norms.
• Collaborate with R&D, manufacturing, and regulatory to address gaps.
• Mentor quality team and manage performance, coaching, succession.

Skills

Leadership

Quality operations management

CAPA management

Regulatory compliance

PFMEA

Data analytics

Team management

Education

Bachelor's Degree in Quality/Engineering or similar

ASQ-CQE desired

Job description

Philips Bedford, MA seeks a Senior Quality Operations Manager to oversee strategic validation initiatives, drive improvements to product quality and manufacturing efficiency, and ensure compliance with FDA regulations.

You will lead CAPA, NC and QN processes, manage a quality team, collaborate with R&D, manufacturing, and regulatory affairs, and support NPI and product transfers to meet quality standards. Office-based role with on-site requirements and possible travel as needed.