Quality Systems Specialist

Philips UK

Ciudad De Panama, Panama
Fully remote
Quality management system compliance
Qms process documents revision
Fda regulated medical device manufacturing
The Quality Systems Specialist is responsible for supporting the establishment of a compliant/ effective Quality Management System (QMS), developing /revising QMS process documents, such as SOPs and quality manuals, ensuring their accuracy/currency, as well as other QMS related responsibilities

Job Summary

  • The Quality Systems Specialist is responsible for supporting the establishment of a compliant/ effective Quality Management System (QMS), developing /revising QMS process documents, such as SOPs and quality manuals, ensuring their accuracy/currency, as well as other QMS related responsibilities.
  • Participates in the effective deployment and continuous improvement of QMS processes in the assigned area/areas such as document control, training, and audits, by providing technical expertise and ensuring compliance with regulatory standards.
  • Philips is a health technology company built around the belief that every human matters, aiming to ensure everyone, everywhere has access to quality healthcare.

Matching Summary

The Quality Systems Specialist is responsible for supporting the establishment of a compliant/ effective Quality Management System (QMS), developing /revising QMS process documents, such as SOPs and quality manuals, ensuring their accuracy/currency, as well as other QMS related responsibilities.

Skills & Requirements

Must-have

  • Quality Management System compliance
  • QMS process documents revision
  • FDA regulated medical device manufacturing
  • global medical device regulations
  • ISO13485
  • 21 CFR 820
  • EUMDR

Nice-to-have

  • cross-functional team collaboration
  • risk management activities
  • problem-solving sessions
  • professional expertise development

Key Requirements

  • Minimum 2+ years experience
  • Bachelor's Degree in Engineering, Sciences, or similar
  • Advanced English communication (verbal/written)
  • Experience with QMS, SOPs, Audit support, CAPA, root cause analysis
  • Understanding of ISO9001

Work Rights

Not specified

Tailored Resume

Cover Letter