Description
What better time to take up a new role than at the start of a new year. There is a fantastic opportunity to grow an Athlone based company as a Senior Quality Systems Engineer.General Function:
Will have the responsibility and the authority to implement the duties listed below:-
Main duties
CAPA System
1. Act as CAPA administrator for the site.
2. Assist CAPA champions with documentation associated with CAPA.
3. Track progress on all CAPAs and escalate all issues to senior management.
4. Host monthly CAB Board Meetings and issue minutes.
5. Compile CAPA metrics & Quality Data Input Sources for Athlone and Boulder.
Complaint Handling and Failure Investigation
1. Act as SME (subject matter expert) with respect to complaint handling for the Athlone site.
2. Act as the main liaison person between the plant and Product Monitoring.
3. Ensure that failure investigation is being completed in a timely fashion in keeping with plant KPIs.
4. Complaint trending and associated metrics
5. Approval of site Failure Investigations
6. Work with Product Monitoring with respect to the compilation of HHEs (Health Hazard Evaluations) where applicable.
7. Compile trending for monthly call with Product Monitoring.
Quality Systems Trending
1. Compile monthly Quality Reports.
2. Compile monthly raw data for Quality KPIs.
3. Compile trending for Operations Reviews and Management Reviews.
Internal Auditing
1. Act as SME with respect to Internal Auditing for the site
2. Assist internal audit team with respect to planning/content of audits/ audit reporting / corrective action plans
3. Organise training to the various standards as required
4. Co-ordinate the Internal Audit schedule
5. Track progress to schedule on a weekly basis reporting progress/issues to management.
Other Duties
Co-operate with his or her employer or any other person to enable the company to comply with relevant Company and Corporate requirements and legislation governing health and safety as principally contained in the 'Safety, Health and Welfare at Work Act 2005 and the Safety , Health and Welfare at Work (General Application Regulations) 2007'.
Report to supervisors or management any accidents/near misses or any defects in the workplace or any infringement of any relevant Company requirements which may endanger their own safety, health and welfare of that or others.
Abide by environmental site procedures to ensure that environmental legal permits and licences conditions are met and waste reduction management initiatives are implemented.
Report all environmental incidents to management and participate in environmental training.
Personnel Specification:
Education: A third level qualification in quality or a related discipline. A good understanding ISO 13485, FDA QSRs, JPAL and Canadian Medical Device regulations is desirable for this position in tandem with strong analytical and computer literacy skills.
Experience: Five or more years' experience in a quality role (ideally QE) within the Medical Device industry is essential for this position.
This opportunity comes at the perfect time for those looking to begin the New Year with a new role. This is a fantastic chance to join a growing company during an exciting period for the business. If this role interests you please send an up to date CV for immediate consideration.