Manager Ii- Quality Assurance

467

Quality culture promotion
Regulatory and customer requirements
Quality system strategic platform
Promote a strong Quality Culture and awareness of regulatory and customer requirements throughout the affiliate, driving awareness of the Quality System as a strategic platform for the business

Job Summary

  • Promote a strong Quality Culture and awareness of regulatory and customer requirements throughout the affiliate, driving awareness of the Quality System as a strategic platform for the business.
  • Engage with the Leadership and functional teams to ensure high standards of compliance to quality system requirements, coach more junior QA team members, and support activities related to assigning QA responsibilities and management of resources.
  • Participate in activities required for an effective Quality Management including self-inspections, supplier qualifications, CAPA process, management review, change control, risk management, and contribute to external audits by Notified Bodies and Health Authorities as needed.

Matching Summary

Promote a strong Quality Culture and awareness of regulatory and customer requirements throughout the affiliate, driving awareness of the Quality System as a strategic platform for the business.

Skills & Requirements

Must-have

  • Quality Culture promotion
  • Regulatory and customer requirements
  • Quality System strategic platform
  • Compliance to quality system requirements
  • GMP requirements
  • ISO 13485, EU-MDR, GDP
  • CAPA process management
  • Risk management
  • GxP supplier qualification and monitoring

Nice-to-have

  • Coaching junior QA team members
  • Continuous improvement initiatives
  • Operational excellence
  • Problem-solving skills

Key Requirements

  • Managerial experience in Quality Assurance
  • Experience with GxP regulations
  • Experience with ISO 13485
  • Experience with EU-MDR
  • Experience with GDP

Work Rights

Not specified

Tailored Resume

Cover Letter