Valued Team member: We are glad you are exploring new opportunities within Zimmer Biomet!
What You Can Expect
The Senior Quality Systems Engineer is responsible for ensuring compliance with established requirements and standards for products and processes through effective implementation of the Quality Management System (QMS) at our Shannon and Galway site.
This role will lead and support QMS processes, including CAPA, Issue Evaluations, Quality Management Reviews, internal and external audits, and change management activities. The position also focuses on simplifying processes, driving innovative solutions, and leveraging technology and AI tools to enhance efficiency. The role requires strong collaboration across functional departments and interaction with external experts to achieve quality objectives.
How You'll Create Impact
- Develop, implement, and continuously improve QMS processes, procedures, and instructions.
- Act as SME for CAPA and Issue Evaluations, ensuring timely and effective closure.
- Lead and maintain the internal audit program and support external audits of the site.
- Host and manage regulatory inspections, including Notified Bodies (NBs) and FDA visits.
- Support change management activities, preferably using Windchill or similar PLM systems.
- Drive simplification of processes and implement innovative, technology-driven solutions, including AI-based tools for quality improvement.
- Prepare and lead Quality Management Reviews to ensure QMS effectiveness.
- Collaborate with operational/manufacturing groups and suppliers to resolve and prevent quality issues.
- Provide training and coaching on QMS requirements to business users.
What Makes You Stand Out
- Strong knowledge of quality assurance techniques (inspection methods, statistical sampling, validation, SPC).
- Expertise in CAPA, change management, and internal auditing.
- Ability to apply innovative solutions and technology to optimize quality systems.
- Excellent communication and leadership skills; ability to host regulators confidently.
- Project management skills with ability to manage diverse tasks simultaneously.
- Ability to work independently and make sound decisions.
Your Background
- Bachelor’s degree in engineering or scientific discipline (or equivalent with CQE certification).
- Minimum 5+ years of experience in Quality Systems, Quality Engineering, or Quality Compliance within a regulated industry (medical device preferred).
- Experience with Windchill or similar PLM systems highly desirable.
- Proven experience hosting regulatory inspections (NBs, FDA).
- Familiarity with Microsoft Office Suite.
EOE/M/F/Vet/Disability
