Quality Compliance Specialist

2 weeks ago


StokeonTrent, Stoke-on-Trent, United Kingdom Page Group Full time
Manage the audit programme with internal staff / suppliers / customers / regulatory authorities / Notified Bodies.

Coordinate investigations relating to audit nonconformities.

Client Details


My client is an international medical device company that engineers, manufactures and markets world leading products for use in infection management in bone and soft tissue.

They are rapidly expand and are in need of assistance in their compliance department.

Description

  • Assist with investigating Customer Complaints, nonconformities and opportunities for improvement.
  • Identify Root Cause/s of nonconformance / customer complaints.
  • Assist /oversee Risk assessments (product and process).
- collect data for trending and analysis to support communication meetings (Management Review Meetings, Quarterly Quality Review Meetings).

Profile

  • Worked in a quality / manufacturing environment within a regulated industry, 5+ years auditing experience.
  • Level 6 degree or equivalent in scientific discipline (or 5+ years QMS / QA / auditing role).
  • Working knowledge of QMS principles e.g. policies and procedures, regulatory requirements, internal and external audits, risk assessment, CAPA.
  • Excellent verbal, nonverbal and written communication skills. Accepts responsibility and able to prioritise tasks.
  • Qualified Lead Assessor. Any QMS / QA related training.
  • Worked within healthcare (medical devices or pharmaceutical) manufacturing.
  • Working knowledge of QMS / GMP Procedures e.g. ISO 13485, ISO 14971, MDR (EU), QSR (US).
  • Able to act on initiative and exhibit leadership qualities.

Job Offer

  • Opportunity to work for a life changing and market leading Medical Device Company.
  • Competitive Salary with great benefits.
  • Fantastic platform for career progression.

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