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Quality Management Director

hace 2 semanas

Alajuela, Alajuela, Costa Rica Freudenberg Medical Srl. A tiempo completo
Job Title: Quality Management Director

Freudenberg Medical Srl. is a leading provider of medical device design and manufacturing solutions.

Job Description:

We are seeking an experienced Quality Management Director to lead our quality management system, ensuring compliance with regulatory requirements such as ISO 13485, MDD 93/42/EEC, MDR 2017/745, and FDA QSR - 21 CFR Part 820.

Main Responsibilities:
  • Lead the implementation and maintenance of the quality management system, including all FMCR processes.
  • Designate Management Representative & Executive Officer for Notified Body & Customer Audits.
  • Management Representative responsibilities include:
    • Reporting to FMCR management on the performance of the quality management system and the need for improvement.
    • Promoting awareness of regulatory and customer requirements.
    • Leading the Quality Assurance Function: Departmental liaison to ensure products manufactured meet customer & regulatory requirements.
    • Ensuring new product introductions & change controls are effectively managed in accordance with regulatory requirements when appropriate.
    • Leading the Customer Complaint investigation process, vigilance (Medical Device Reporting requirements and product recalls where necessary).
    • Leading the Plant Corrective & Preventive action program.
    • Participation & Maintenance of plant continuous process improvement programs.
    • Leading the Internal & External Audit Program(s) including quality system & product requirements are included in the plant Training Program(s).
    • Final Disposition of Non-conforming product including control of re-work & MRB co-ordination.
    • Training QC employees in procedures and good manufacturing practices.
    • Supporting Data Protection Compliance Officer and championing compliance with data protection legislation.
Qualifications:
  • Bachelor's degree in Engineering or Master's degree.
  • Six Sigma Black Belt Certification.
  • Minimum 7 years of Quality, Manufacturing, and/or Product Development experience.
  • 5+ years minimum of medical device experience.
  • Demonstrated ability to manage, coach and mentor employees.
  • Excellent English Skills working with teams in the USA.
  • Experience in a metric-driven culture.
  • Previous experience participating in or leading a Quality audit or section of an audit.
  • ISO Quality Systems requirements, FDA GMP, and QSR.
  • Electronic Quality Management System.
  • Able to review and analyze data and documentation.
Benefits:
  • Performance-related bonus.
  • Diversity & Inclusion initiatives.
  • Car allowance.
  • Sustainability / Community service opportunities.
  • Occupational safety.