Senior Quality Engineer
Contact Shauna Mooney
1. Salary: €70,000 - €80,000
2. Location: MunsterLimerick
3. Sector: Pharma & Life Sciences
4. Contact: Shauna Mooney
5. Mobile: +353851865273
Are you an experienced Quality Engineer looking for an opportunity to make a real impact in the medical devices industry? We are seeking a Senior Quality Engineer to join a leading global company based in Limerick, where you'll play a crucial role in ensuring the highest standards of quality and compliance in medical device manufacturing.
A Quality Leader responsible for driving global and internal programs, system development, and continuous improvement initiatives related to the operation of the Quality Management System.
Benefits:
6. 26 days of annual leave
7. Competitive salary package
8. Comprehensive benefits including discretionary bonus, pension plan, family healthcare, and more
9. Collaborative and supportive work culture
10. Regular social events
11. Opportunities for learning, development, and career progression
Responsibilities:
Key responsibilities will include (but are not limited to) the following:
12. Lead, support, and monitor the Corrective and Preventive Action (CAPA) process.
13. Oversee and evaluate the effectiveness of the Internal Audit process.
14. Manage and host Customer and Regulatory audits.
15. Act as site project leader for Teleflex Global Quality Management System (QMS) projects as required.
16. Serve as the site quality technical lead for software approvals and Information System projects when necessary.
17. Prepare and present monthly and management review data metrics on Quality System performance, including Complaints, Non-Conformances (NCs), CAPA, Audits, and supplier performance.
18. Act as the designated Management Representative in the absence of the Quality Manager when required.
19. Drive performance improvements and process enhancements within the Quality Management System, continually seeking ways to improve efficiency.
20. Lead, motivate, and develop the team and self to meet both performance and growth objectives.
21. Develop and communicate long-term and short-term departmental business objectives, aligning them with organizational goals.
22. Lead, motivate, and mentor cross-functional teams to ensure timely achievement of project milestones in line with business needs.
23. Collaborate with other departments to ensure professional, timely responses to quality, regulatory, and customer queries.
24. Monitor and enforce compliance with Good Manufacturing Practices (GMP) and QMS requirements.
25. Lead and manage quality system improvement projects as directed.
26. Ensure full adherence to regulatory requirements.
27. Promote and ensure compliance with Quality and Environmental, Health, and Safety (EHS) policies and procedures at all times.
Requirements:
28. A Level 8 degree in Quality or a related Engineering degree discipline is essential.
29. A minimum of 5-10 years' experience in Quality Systems Management within the Medical Device or Component Industry.
30. Certified Quality Engineer (CQE) certification is desirable.
31. Strong technical report writing abilities.
32. Proficiency in statistical methods such as Design of Experiments (DOE), Statistical Process Control (SPC), and sample comparison.
33. Solid understanding of Risk Management and validation principles.
34. Previous experience managing project teams is desirable.
35. Strong planning and organizational skills, with experience in overseeing, sponsoring, and managing projects and programs.
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