- 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).
- 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.
- Lead audit preparation activities for the site and actively participate in external audits by Notified Bodies and Health Authorities.
- Overall responsibility for CAPA system, Internal Audit program, Management Review, Documentation and associated key facility metrics.
- 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.
- Ensure Quality System and Documentation processes are lean, compliant, user-friendly and are well understood through-out the organization.
- Member of the Site Operational Leadership team involving collaborating with multiple departments to deliver onsite strategic targets and objectives.
- Drive and enhance a compliance culture throughout the site.
- Represent the site at corporate discussions relating to new and evolving Quality System requirements.
The ideal candidate will have:
- Expertise in quality system standards and regulations, including FDA 820, ISO 13485 and international standards, such as EU MDR, CMDCAS.
- Strong leadership skills to engage and motivate a high performing team with focus on continuous improvement.
- Excellent communication and interpersonal skills with the ability to influence across a variety of departments and disciplines.
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
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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