Due to continued expansion of their operations our client a well-established Multinational Healthcare Manufacturer now require a qualified and experienced Quality Systems Specialist
The Quality Systems Specialist will be be responsible for providing quality systems support for to all processes related to QMS. Assures that quality standards are maintained and assist with the implementation and compliance of the quality management program. Support company goals and objectives, policies and procedures, quality systems, and FDA regulations.
This is a permanent role based in The Midlands with excellent progression opportunities
Key Responsibilities of Quality Systems Specialist:
- Manage all controlled documentation in all its media variants.
- Create and maintain Controlled Document Stations (CDS) as appropriate including suppliers as necessary.
- Ensure distribution of specification to suppliers is maintained.
- Create user accounts and provide rights / roles accordingly for Manufacturing, Ireland personnel, as appropriate.
- Liaise with disposables team to ensure all relevant documents, various media, is compliant.
- Manage change control system through Smart.solve.
- Train Manufacturing, Ireland personnel on change order process.
- Assist Manufacturing personnel with creating and/or processing change orders, including the completion of risk assessment and validation requirements.
- Tracking and management of Ireland generated change orders.
- Generate management metrics on change order system.
- Working in coordination with the Quality Systems Manager to prepare, maintain and execute the annual local audit schedule and any subsequent revisions.
- Reviewing and approving the results of internal audits conducted in accordance to this procedure.
- Informing Management about the Internal Audit process effectiveness.
- Closing the audit.
- Maintaining the audit and Auditors training files.
- Preparing Metrics on Internal Audits.
- Coordinating Internal Audit review meetings.
- Bachelor’s degree in Engineering, Science or related subject.
- 5 years industry experience. Medical device experience strongly preferred.
- Experience in working in High Volume Production Facility
- Strong computer and document management skills
- Familiarity with ISO quality systems (ISO9001, ISO14001 and/or ISO13485)
Please send an up to date CV and cover letter to John Reid at The RFT Group / firstname.lastname@example.org / on 01-2302400 / www.rftgroup.ie
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The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors.