|Role Type||Fixed Term Contract|
Senior Quality Systems Supervisor
Job ID: JOB-11920
Senior Quality Systems Supervisor- Initial FTC
A global leader in medical technology is current seeking a Senior Quality Systems supervisor to join their team in West Meath which is commutable from Galway, Roscommon, & Meath. The primary focus of of this role is managing people to include accountability for mentoring, developing and coaching staff on meeting/exceeding performance expectations and defined objectives, providing leadership to staff ensuring the prioritization of strategic and department level initiatives.
- Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.
- Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
- Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.
- Prepares reports and/or necessary documentation (ex Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external.
- Ensures the quality assurance programs and policies are maintained and modified regularly
- Act as CAPA SME for the site. Track progress on all CAPAs and host monthly CAB meetings, issue minutes and track action items to closure
- Co-ordinates and collates data for management review
- Liaise with product monitoring in relation to complaints (main plant contact)
- Ensure that failure investigation is completed in a timely manner in line with plant KPIs.
- Work with Design QA and Product Monitoring with respect to compilation of risk assessments associated with customer complaints where applicable.
- Act as SME with respect to Internal Auditing for the site. Co-ordinate the internal audit schedule and track progress to same on a weekly basis reporting progress to all stakeholders
- Assist the internal audit team with respect to planning/audit reports and corrective action plans.
- Ensure that internal auditors are trained and proficient with the applicable regulations.
- Provision of trending and associated metrics for all CAPAs, Complaints, and Internal Auditing KPIs.
- A third level qualification in quality or a related discipline.
- A good understanding ISO 13485, FDA QSRs, JPAL and Canadian Medical Device regulations is desirable for this position in tandem with strong analytical and computer literacy skills
- Five or more years’ experience in a quality role (ideally quality systems)
- Lead auditor qualification preferred, not required
For further information on this role in please contact Mark Wilson on 0860449473 or email email@example.com
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