I'm currently working with a leading Medical Device company located in Cork who have an immediate opening for a Senior Quality Systems Manager. This is an excellent opportunity to join a growing Medical Device company in a Senior Management role as they continue to expand.
This particular company is renowned for its work-life balance where it really implements the 39 hour week. The position is permanent and comes with an excellent benefits package. (salary negotiable depending on experience)
Reporting directly to the Site Head of Quality, the Senior Quality Systems Manager is responsible for the compliance of operations in accordance with regulatory requirements and corporate expectations at the site.
* 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.
* 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
If you are interested in making the move into a managerial role or are an experienced manager looking for a new challenge, then please apply directly for immediate consideration.
To find out more about Real please visit www.realstaffing.com
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales