Quality Systems Engineer

Philips UK

Bedford, United States
Base: $102,480 to $163,968; bonus/equity: annual i...
Fully on-site
Qms compliance
Capa processes
Document control
Philips UK is seeking a Quality Systems Engineer for their Bedford, MA location, responsible for ensuring an efficient and compliant Quality Management System (QMS) in a regulated medical device environment. The ideal candidate will have over five years of experience in quality operations and a strong background in FDA regulations, CAPA processes, and data analysis

Job Summary

  • The Quality Systems Engineer is responsible for ensuring an efficient/compliant Quality Management System (QMS), including analysis, development and revision of QMS processes, performance monitoring and continuous improvement, ensuring accuracy and compliance with relevant standards.
  • Participates in continuous improvement initiatives within the QMS, proposing and implementing enhancements to processes, tools, and systems to drive overall quality performance and operational excellence.
  • Prepares for and participates in external regulatory audits and inspections by ensuring readiness of documentation, processes, and records, and provide responses to audit findings in collaboration with stakeholders.

Matching Summary

Match Score: 85

Philips UK is seeking a Quality Systems Engineer for their Bedford, MA location, responsible for ensuring an efficient and compliant Quality Management System (QMS) in a regulated medical device environment. The ideal candidate will have over five years of experience in quality operations and a strong background in FDA regulations, CAPA processes, and data analysis.

Salary

Base: $102,480 to $163,968; Bonus/Equity: Annual incentive bonus, sales commission or long-term incentives may be offered; Benefits: Generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more

Skills & Requirements

Must-have

  • QMS compliance
  • CAPA processes
  • Document Control
  • Risk assessments
  • Cross-functional teams

Nice-to-have

  • Mentoring less experienced engineers
  • Innovative approaches
  • Proposing and implementing enhancements

Key Requirements

  • 5+ years experience in FDA regulated (ISO 13485) medical device quality operations/manufacturing
  • Experience managing/maintaining training metrics/matrix
  • Proven experience leading cross-functional teams
  • Detailed experience/knowledge in CAPA processes
  • Experienced in Data analysis, understanding QMS metrics/KPIs
  • Bachelor’s Degree in Quality, Engineering or similar disciplines

Work Rights

US work authorization required

Tailored Resume

Cover Letter