Senior Quality Engineer

Our client, a Global provider of Medical Technology is seeking a Senior Quality Engineer based in Limerick.

This role is responsible for driving quality management systems (QMS) and customer requirements throughout the product lifecycle, encompassing new product development, new product introduction, commercialization, sustaining, and end-of-life phases.

It involves effective quality input, document review, and communication with all stakeholders while ensuring compliance with Good Manufacturing Practices (GMP) and QMS requirements within the Value Stream.

Key Responsibilities:

1. Demonstrate technical excellence, including:
   • Development of specifications and critical-to-quality (CTQ) mapping.
   • Test method development and validation.
   • Process validations and implementation of Critical Control Points (CCP).
   • Error-proofing and process monitoring using Statistical Process Control (SPC).
   • Handling complaints and managing non-conformities.
   • Conducting risk and impact assessments.
   • Investigating root causes and developing solutions.
   • Planning product testing and release.
   • Managing change and conducting audits.
   • Applying critical thinking and technical writing skills.
2. Lead quality efforts on multi/cross-functional project teams to achieve milestones and results.
3. Represent the company in customer interactions related to product, process, and system quality elements in a professional and constructive manner.
4. Ensure that customer product requirements are defined and implemented within the site’s QMS.
5. Proactively engage in new product development to facilitate a smooth transition from development to production.
6. Drive continuous improvement initiatives across the board and take proactive steps to enhance processes daily.
7. Take ownership of and drive Safety/Quality/Service/Cost metrics in collaboration with the Value Stream Leader team.
8. Lead by example and exhibit agreed-upon behaviors.
9. Align goals and objectives for the Value Stream in collaboration with management.
10. Execute Lean initiatives and promote a culture of continuous improvement.
11. Commit to developing, coaching, and motivating both self and the team.
12. Lead the Value Stream through influencing skills, even without hierarchical authority over all team members.
13. Build relationships with key stakeholders in the company and address their communication and information needs.
14. Ensure full compliance with regulatory requirements and adherence to Quality and Environmental Health and Safety (EHS) policies and procedures.

The Ideal Candidate:

• Bachelor’s degree in a Science, Engineering, or quality-related discipline is essential
• Over 8 years of quality technical experience in a similar environment.
• Desirable certification as a Quality Engineer (QE).
• Proficiency in technical report writing.
• Competency in risk management tools and process validation.
• Statistical analysis skills.
• Proficiency in structured problem-solving tools.
• Understanding of Lean Principles, with Lean Six Sigma (LSS) Green Belt certification being desirable.
• Ability to drive projects to completion.
• Adherence to due diligence and compliance principles in all aspects of work.
• Working knowledge of EN ISO 13485, FDA QSR 21 CFR Part 820, and principles of GMP in the Medical Device Industry.
• Ability to comprehend customer/vendor relationships.
• Building appropriate relationships with customers and vendors.
• Handling difficult customer or vendor communications.
• Ability to influence customers/vendors when necessary.
• Understanding of key business drivers.
• Awareness of the impact of the role on key business drivers.
• Basic understanding of how various departments contribute to the overall business.
• Effective verbal and written communication.
• Leadership in conducting meetings.
• Collaboration within cross-functional teams.
• Strong interviewing skills.
• Ability to influence employees who do not report directly.