Senior Quality Operations Leader - Medical Device NPI & CAPA

Mass Digital Health; Massachusetts; On-site; USD 134,000 - 213,000; Full time

Benefits offered by this job

Total Rewards benefits program

Generous PTO

401k with match

HSA with company contribution

Stock purchase plan

Job summary

Philips is seeking a Senior Quality Operations Manager-Advanced Imaging in Bedford, MA to lead quality operations for medical devices. The role drives CAPA/NC/QN processes, process validation, and risk management while coordinating across R&D, manufacturing, and regulatory affairs to uphold regulatory standards and excellent product quality.

You will manage a quality team, oversee audits, and support PFMEA assessments, change/risk management, and NPI/product transfers, ensuring robust quality

Qualifications

• 10+ years of experience in FDA-regulated (ISO 13485) medical device quality operations/manufacturing environments.
• 3+ years of proven experience managing quality teams—budgeting, workforce planning, performance management.
• Experience managing CAPA processes, non-conformances, root cause analysis and preventive actions.
• Knowledge of Quality, Reliability and PMS insights for continuous improvement across product lifecycle.
• Experience collaborating with R&D, manufacturing and regulatory teams; supplier quality focus.

Responsibilities

• Oversee strategic process validation initiatives and improve product quality/manufacturing efficiency.
• Manage CAPA, non-conformance, and QN processes with rigorous investigations and root-cause analyses.
• Lead PFMEA assessments and validation activities for design changes and NPI/product transfers.
• Drive supplier quality improvements and cross-functional collaboration across R&D, manufacturing, and regulatory teams.
• Maintain manufacturing quality systems and lead risk management to enable NPI completion and transfers.

Skills

Quality operations

CAPA

PFMEA

Regulatory compliance

Root cause analysis

Continuous improvement

Data analytics

Team leadership

Education

Bachelor's Degree in Quality or Engineering

ASQ-CQE

ISO Lead Auditor

Job description

Philips is seeking a Senior Quality Operations Manager-Advanced Imaging in Bedford, MA to lead quality operations for medical devices. The role drives CAPA/NC/QN processes, process validation, and risk management while coordinating across R&D, manufacturing, and regulatory affairs to uphold regulatory standards and excellent product quality.

You will manage a quality team, oversee audits, and support PFMEA assessments, change/risk management, and NPI/product transfers, ensuring robust quality