Job Description
Our client is seeking an experienced Quality Engineer who has proven success in quality and validation activities. You will provide quality support for site activities, ensure compliance with standards and collaborate with cross-functional teams. The ideal candidate will have experience in quality assurance and will have the ability to communicate effectively. You will be responsible for maintaining quality systems and continuous improvement initiatives.
Key Responsibilities:
1. Identifies and resolves complex exceptions to work assignments
2. Has the responsibility and independent authority to make decisions related to product quality, including the disposition of non-conforming product
3. Continually seeks to drive improvements in product and process quality
4. Knowledgeable on MDR and QSR standards, constantly promoting awareness of best industry practices, making appropriate decisions daily utilizing the quality engineering manager/site QA Director as the final arbitrator on critical quality decisions
5. Fully conversant with validation techniques and associated regulatory requirements including analysis of customer feedback and complaints
6. Evaluates in conjunction with EHS new equipment/processes/chemicals for environmental impact/effect to eliminate or lessen such impacts/effects
7. Compiles and analyses operational, test and validation data to establish technical specifications and performance standards for newly designed or modified products and processes
8. May participate directly in a new product/technology transfer to ensure compliance to all internal and regulatory requirements
9. Uses knowledge of Six Sigma, Statistical Analysis and Lean principles to investigate and solve problems and improve quality
10. Possesses excellent collaboration skills
11. Gives technical guidance to Quality Technicians.
Requirements:
12. A Level 8 Degree or equivalent in an Engineering or Science-related discipline
13. A minimum of 2 years' experience working at Engineering level, ideally within the Medical Device industry or similar highly-regulated
14. Experience with internal and external audit processes
15. A team player, who can demonstrate best practices in line with the department and site objectives and someone who is fully motivated to achieve.
Benefits
16. Competitive and attractive employee compensation package
17. Pension contributions
18. Health insurance
19. Paid public holidays.
Location: Galway, Ireland | onsite