Base: $102,480 to $163,968; bonus/equity: annual i...
Fully remote
Qms compliance and documentation
Audits and document control
Capa process expertise
The Quality Systems Engineer is responsible for maintaining an efficient and compliant Quality Management System that meets regulatory requirements and drives continuous improvement
Job Summary
The Quality Systems Engineer is responsible for maintaining an efficient and compliant Quality Management System that meets regulatory requirements and drives continuous improvement.
Philips offers a comprehensive Total Rewards benefits program including generous PTO, 401k match, HSA contributions, stock purchase plan, and education reimbursement.
This is an on-site role based in Bedford, MA requiring at least 3 days per week in-person presence and may require up to 10% travel.
Matching Summary
The Quality Systems Engineer is responsible for maintaining an efficient and compliant Quality Management System that meets regulatory requirements and drives continuous improvement.
Salary
Base: $102,480 to $163,968; Bonus/Equity: Annual incentive bonus and long-term incentives may be offered; Benefits: Comprehensive Philips Total Rewards program including PTO, 401k match, HSA, stock purchase plan, education reimbursement
Skills & Requirements
Must-have
QMS compliance and documentation
Audits and Document Control
CAPA process expertise
Training metrics management
Data analysis of QMS metrics
Cross-functional team leadership
On-site work requirement
Nice-to-have
Mentoring less experienced engineers
Risk assessment and mitigation
Continuous improvement initiatives
Root cause analysis expertise
Building internal and external relationships
Participation in regulatory audits
Use of structured problem-solving methodologies
Key Requirements
Minimum 5+ years FDA regulated medical device quality experience
Bachelor’s Degree in Quality, Engineering or similar
Experience with ISO 13485 standards
ASQ-CQE or ISO Lead Auditor certifications desired
US work authorization required
Residency within commuting distance to Bedford, MA
Work Rights
US work authorization required; no sponsorship provided