Our client, a medical device company in Athlone is currently looking to recruit a Quality Systems Engineer for their site.
Purpose of Job:
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.
- 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 KCI Manufacturing, Ireland personnel, as appropriate.
- Liaise with disposables team to ensure all relevant documents, various media, is compliant.
Change Control System
- Manage change control system through Smart. Solve.
- Train KCI Manufacturing, Ireland personnel on change order process.
- Assist KCI Manufacturing, Ireland 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.
The Ideal Candidate:
- Bachelor’s degree in Engineering, Science or related subject.
- A minimum of 5 years’ industry experience. Medical device experience strongly preferred.
- Excellent Communication Skills
- Experience in working in High Volume Production Facility
- Strong computer skills
- Strong document management skills
- Familiarity with ISO quality systems (ISO9001, ISO14001 and/or ISO13485)
- Good customer relation skills
For further information on this Quality Systems Engineer role please contact Orla Crowley on 086 0449473/ Talent@hero.ie
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