Quality Systems Specialist - Sligo

COLLINS MCNICHOLAS RECRUITMENT

SLIGO

Our client, a leading medical device company in Sligo, is looking to hire a Quality Systems Specialist. Responsibilities: Ensures Quality Systems are implemented and continuously reviewed to ensure compliance with ISO9001 and ISO13485 Quality Management System. Manage and participate in the internal QMS Audit process- Ensure issues arising are communicated and action taken as appropriate. Participate and interface in external audits (Customer, Corporate & Regulatory. Liaise directly with external auditors, customers and corporate on matters concerning quality and corrective preventive action activities arising from product/ system non-compliance. Develop collaborative relationships with all internal and external stakeholders and share best practices. Supplier approval, auditing and performance monitoring. Quality and GMP Training. QMS Documentation Control /Record Keeping. Initiate product hold /containment actions, including completion of non-conforming reports, quarantine notice and any associated rework instruction. Review & approval of process and equipment validation/ qualification. Ensure risk management activities across the site are actively maintained and mitigated. Support the Quality & Regulatory Affairs Manager in meeting the relevant regulatory requirements. Act as customer interface as required. Requirements: Degree in a Quality, Science or Engineering discipline. Minimum of 5 years relevant experience in a Quality role essential, preferably in the Medical Device, Injection Moulding or Toolmaking Industry. Strong knowledge and application of quality system regulations and ISO standards, and able to support an environment that meets the quality goals of the company. ISO13485 Lead Auditor Training supported by practical hands-on experience in QMS auditing. Knowledge of the Six Sigma approach and methodology for eliminating defects in the manufacturing process is desirable. For a confidential discussion and more information on the role, please contact Mark Whelan. mark.whelan@collinsmcnicholas.ie. 071-9142411. For more information on our Recruitment and HR Services, and to see a full list of our available jobs across Ireland, please visit our website at www.collinsmcnicholas.ie. Follow us on LinkedIn and connect with our consultants to discuss all the latest jobs!.

1430 days ago