Quality Systems Engineer
|Job Title:||Quality Systems Engineer|
|Duration:||Fixed Term Contracts|
|REF:||Quality Systems Engineer|
|Contact Name:||David Walsh|
We are currently recruiting for the position of a Quality Systems Engineer on a fixed-term contract.
Functional Area: Quality
Career Framework Title: Quality Specialist
Internal Job Title: Quality Systems Engineer
Job Level: 08
This position supports the Quality System to ensure compliance with integrated ISO standards at the site as well as other medical device standards. This role will work with all areas and functions in the organisation to ensure compliance to ISO standards.
This position will report to the Quality Manager.
- Ensures compliance with all ISO standards on-site, specifically ISO13485.
- Manages, directs and improves the CA/PA process, ensuring good recording and administration and timely closure of all related activities/actions.
- Contributes to the continuous improvement of the Quality System, including the development of quality metrics and dashboard; hold regular team reviews that screen, track, record and publish compliance and improvements.
- Promotes Good Manufacturing practices to ensure the site team adheres to the quality system requirements.
- Participates in key metrics development and reporting across all production lines and all departments.
- Reviews and approves changes to Quality System procedures to ensure compliance to applicable standards and external requirements.
- Review international standards, including related areas (e.g. safety, risk, enviro’ pharma’, food, energy, etc) to identify gaps in the Quality System and inform site management about changes that compromise compliance.
- Co-ordinates the Internal audit process and lead management reviews to ensure the effectiveness of the QMS.
- Assists in the preparation for external and customer Audits offering support across all departments.
- Directs improvements in related quality assurance processes such as NCMR/MRB and the Calibration system.
- Coordinates the documentation of all NPI projects with the Project Managers in addition to maintaining and ensuring the effectiveness of the Change Management System and BOM control for the Business Units.
- Record retention / archive co-ordination. Responsible for the coordination, tracking, and storage of records relevant to the Department/Function, as per the Records Management Program Operating Procedure.
- Ensures the document control system (physical and electronic) is screened, maintained and administrated to effect full revision control with timely notifications in full compliance with the QMS. · Provides regular document control updates and publications as are necessary to ensure QMS compliance.
- Strong organizational skills with good attention to detail.
- Ability to work independently and as a member of a team in a dynamic environment.
- Effective administration, communication and reporting skills.
- Good knowledge of all Microsoft Office applications and ability to operate local quality DBMS system.
- Risk management skills & training (e.g. FMECA, ISO 14971:2007/’12) is desirable.
- Excellent knowledge of ISO 13485 and 21 CFR 820 is essential.
- 3 to 5 years experience in a similar Quality systems role.
- Third Level Qualification or equivalent in quality systems administration area.
- Qualified Lead Auditor desirable.
- Experience in working in a medical device environment would be a distinct advantage
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