Senior Quality Operations Leader: CAPA, PFMEA & NPI

Philips; Bedford (MA); Hybride; USD 134 000 - 213 000; Plein temps

Avantages offerts par ce poste

PTO

401k

HSA

Stock purchase plan

Education reimbursement

Résumé du poste

Philips in Bedford, MA, seeks a Senior Quality Operations Manager to oversee strategic process validation initiatives, drive improvements in product quality and manufacturing efficiency, and manage CAPA/Nonconformance processes. You will lead a quality team and ensure regulatory standards and QMS compliance across NPI and product transfers.

The role requires 10+ years in FDA-regulated medical device quality operations, with at least 3+ years leading teams.

Qualifications

• Extensive experience in FDA-regulated (ISO 13485) medical device quality operations/manufacturing environments.
• Proven ability to manage quality teams, CAPA, non-conformances, and change/risk management (ISO 14971).
• Experience driving process validation/improvement and NPI/product transfers.

Responsabilités

• Oversees strategic process validation initiatives and continuous improvements to optimize product quality and manufacturing efficiency.
• Manages CAPA/NC/QN processes and ensures regulatory compliance and QMS effectiveness.
• Leads quality engineering and assurance tasks to support New Product Introduction and product transfers.

Connaissances

Quality operations

CAPA management

PFMEA

Process validation

Regulatory compliance

Leadership

Root cause analysis

Quality audits

Risk management

Formation

Bachelor’s Degree in Quality/Engineering or related

Description du poste

Philips in Bedford, MA, seeks a Senior Quality Operations Manager to oversee strategic process validation initiatives, drive improvements in product quality and manufacturing efficiency, and manage CAPA/Nonconformance processes. You will lead a quality team and ensure regulatory standards and QMS compliance across NPI and product transfers.

The role requires 10+ years in FDA-regulated medical device quality operations, with at least 3+ years leading teams.