Senior Quality Leader - Advanced Imaging & QMS Excellence

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

Benefits offered by this job

PTO

401k

HSA with company contribution

Stock purchase plan

Education reimbursement

Job summary

Philips in Bedford, MA seeks a Senior Quality Manager-Advanced Imaging to lead the Quality Management System and Design Assurance throughout the product lifecycle. You will drive regulatory readiness, audits, and continuous quality improvements across R&D, Operations and Regulatory Affairs.

The role requires 8+ years in FDA-regulated medical devices, expertise in ISO 13485/14971, 21 CFR, EU MDR and strong leadership, budgeting and coaching skills.

Qualifications

• 8+ years’ experience in FDA-regulated medical device environments.
• Experience leading quality teams, budgeting, performance management and coaching.
• Strong knowledge of ISO 13485/14971, 21 CFR 803/806/820, EU MDR, GMP and GDP.

Responsibilities

• Lead QMS and Design Assurance as a strategic member of the leadership team.
• Oversee QMS compliance with global regulations and standards (FDA QMSR, ISO 13485, MDR).
• Serve as primary quality representative for regulatory inspections and audits.
• Establish and improve quality processes, systems, and procedures for safe, effective products.
• Drive data-based decisions with quality metrics and continuous improvement initiatives.
• Lead CAPA, nonconformances, root cause analysis and corrective actions.
• Oversee design controls, verification/validation, design transfer, and process validation.
• Promote risk management across product development, manufacturing and post-market activities.

Skills

QMS Compliance

Design Assurance

Regulatory Inspections

CAPA Management

Risk Management

Leadership

Education

Bachelor’s Degree in Quality, Engineering or similar

Job description

Philips in Bedford, MA seeks a Senior Quality Manager-Advanced Imaging to lead the Quality Management System and Design Assurance throughout the product lifecycle. You will drive regulatory readiness, audits, and continuous quality improvements across R&D, Operations and Regulatory Affairs.

The role requires 8+ years in FDA-regulated medical devices, expertise in ISO 13485/14971, 21 CFR, EU MDR and strong leadership, budgeting and coaching skills.