Highly Skilled Quality Professional

5 days ago

Waterford, Waterford, Ireland beBeeSpecialist Full time €90,000 - €105,000
Job Title

Senior Specialist, Quality, Integrated Systems

,About the Role

This position plays a critical part in ensuring product quality and patient safety through the effective execution of quality processes. The successful candidate will be responsible for providing quality direction, governance, and Quality best practices across the Quality Management System and the programs they support.

,Key Responsibilities
  • Lead project planning activity and develop comprehensive project plans including scope, timelines, budget, resources, and project success criteria.
  • Collaborate with cross-functional teams to coordinate project execution and ensure that project objectives and success criteria are met.
  • Provide Quality direction to multiple concurrent product development programs to ensure product and process compliance to all applicable regulatory and cGMP requirements.
  • Author, review, and/or approve design history documentation and design manufacturing documentation.
  • Support the development and maintenance of product or process risk and hazard analysis.
,Requirements
  • Bachelor's Degree in Engineering or Science or equivalent experience required.
  • Minimum 5 years of experience in a regulated industry (e.g., Medical Device), including Product Manufacturing and Post Market Surveillance Activities required.
  • Demonstrated experience (4+ years) independently defining, planning, and executing projects in highly regulated environments with a track record of success required.
,Preferred Qualifications
  • Manufacturing Six Sigma Green Belt Certification or Black Belt Upon Hire preferred.
  • Quality Certified Quality Technician-ASQ (CQE or CQA) Upon Hire preferred.
  • ISO 13485/15378/9001 Auditor or Lead Auditor Training / Certification Upon Hire preferred.
,Travel Requirements

10%: Up to 26 business days per year

,Additional Information

We offer excellent benefits and a supportive work environment. If you're looking for a challenging role with opportunities for growth and development, we encourage you to apply.

West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status.

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