Senior Quality Systems Manager

  • Cork
  • Permanent
  • JO-1902-64281_1550839836

Summary


Key Responsibilities:

  1. Ensure QMS compliance with the appropriate internal and external regulatory requirements (including but not limited to Site, Division, Corporate, FDA, ISO, MDD, EU MDR, and individual country requirements).
  2. Engage and motivate the Quality Systems and Documentation teams by communicating effectively and providing regular feedback to direct reports through performance reviews, recognition, career conversations and coaching.
  3. Lead audit preparation activities for the site and actively participate in external audits by Notified Bodies and Health Authorities.
  4. Overall responsibility for CAPA system, Internal Audit program, Management Review, Documentation and associated key facility metrics.
  5. Manage and provide guidance to non-conformance investigations ensuring formal structured approach to root cause analysis and problem-solving, ensuring adequate corrective actions and prevention plans are implemented.
  6. Ensure Quality System and Documentation processes are lean, compliant, user-friendly and are well understood through-out the organization.
  7. Member of the Site Operational Leadership team involving collaborating with multiple departments to deliver onsite strategic targets and objectives.
  8. Drive and enhance a compliance culture throughout the site.
  9. Represent the site at corporate discussions relating to new and evolving Quality System requirements.



The ideal candidate will have:

  1. Expertise in quality system standards and regulations, including FDA 820, ISO 13485 and international standards, such as EU MDR, CMDCAS.
  2. Strong leadership skills to engage and motivate a high performing team with focus on continuous improvement.
  3. Excellent communication and interpersonal skills with the ability to influence across a variety of departments and disciplines.


Education

Minimum: Degree from an accredited institution in a Quality Management, Science, Engineering or related discipline
Preferred: Master's Degree in Quality Management or related Science discipline or business qualification

Experience

Minimum: 5 years' experience in a Medical Device or related field having comparable technology and regulatory requirements. Three years supervisory experience
Preferred: 5 years supervisory experience in a Medical Device or Pharmaceutical industry with experience in Health Authority audits.
Alternative combination: Advanced education in a relevant field may be substituted for experience

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