Job for Quality Engineer in Midlands Job in Kildare Ireland
Flexsource
About the Job
This job is primarily focused on supporting engineering activities in all aspects of product robustness changes and compliance related projects, ensuring technical correctness and compliance with requirements of global regulations. This job operates as an essential function in the overall strategy for improved assurance of delivered product quality and continuity of established QMS and to support the growth of the organisation.
Duties and Responsibilities
This job will involve working with the engineering department where you would be required to; co-develop design verification and validation protocols for new products and for change on existing products, conduct design verification and validation studies, review and approve protocols, studies, and perform general oversight responsibilities for validation process, for both equipment and processes.
In this job you would be a primary member of New Product Introduction Teams, both working in partnership with the Product Development and Tullamore Engineering Depts. for process and product understanding and technical assessment.
In this job you would be a member of the Engineering Peer Review of design approach, layouts, worse case best case analysis, tolerance stack up, design architecture, regulatory compliance, and assessing supporting documentation.
This job will involve working with other client sites where you would be responsible for project managing the site, QMS alignment to ensure compliance stability and to allow for duality of manufacture of product, as part of business risk mitigation initiative.
This job would involve the review of MDHA and D-FMEA updates with RC / RA dept. On new product or product changes, mitigating risk and controlling compliance to risk management and cGMP requirements.
This job would require support of P-FMEA activities with QA and or Process Engineering group.
In this Job you would be required to work closely with the QA/RA Manager to effect roll-out of new quality initiatives and corporate SOPs.
Qualifications
• Min 3-5 years experience at Quality Engineering Level within a FDA or ISO 13485 cGMP regulated medical device manufacturer, preferably in electronics or electromechanical based devices.
• Degree level in Electronics Engineering (desirable).
Personal Profile of desirable Candidate
• Good project management and organisational abilities
• Strong interpersonal and communication skills, including oral and written reports
• Pro-active worker with a proven ability to work under one's own initiative and a strong team player.
• Solid technical ability
• Wiliness to travel to other company sites as part of duties.