A Quality Systems Engineer is required by CareerWise Recruitment for our Westmeath based client. Reporting to the Quality Systems Manager, you will be responsible for providing quality systems support for to all processes related to QMS. Assure that the 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. Please contactTom Devaney for more information.
Role of this position
- 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 company 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 personnel on change order process.
- Assist 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.
- Bachelors Degree (LEVEL 8) 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
- Ability to present an independent opinion
- Good Presentation skills
Please call Tom Devaney today for further information on 091-758771 or email: email@example.com
CareerWise Recruitment (In Search of Excellence)