Our Client is a global technology group that strengthens its customers and society long-term through forward-looking innovations. They Group employs some 50,000 people in 60 countries worldwide and generates sales of over 10 billion euros.
They make products that save and improve the lives of people every day, all around the world.
Our client has an exciting place to work with lots of opportunity to learn, develop, and grow your career. Come join us and together we can make a difference in the future of healthcare.
Responsibilities
- Be the leader of Quality within assigned area. Act as the designate for the Quality Manager.
- Foster a culture of unwavering commitment to quality and customer satisfaction across all company activities.
- Ensure the effectiveness of the Quality System for the products under production, ensuring full compliance with customer and regulatory standards.
- Identify and comprehensively document all customer requirements in Cambus Medical's manufacturing documents and ensure their successful integration.
- Provide expert guidance on quality matters for validation, change management, problem-solving, and product disposition activities.
- Collaborate with customers and suppliers on quality-related issues and new product introduction projects, maintaining professional and positive relationships at all times.
- Investigate and resolve product and process quality issues, including customer complaints, in a timely and effective manner using the Cambus Medical Corrective and Preventive Action (CAPA) system.
- Implement effective change control practices.
- Lead quality-centric projects, ensuring their on-time delivery and adherence to budget constraints.
- Actively participate in project teams and deliver on commitments as per the established schedule and budget.
- Function as the lead quality auditor, conducting supplier quality audits and serving as a guide during customer and regulatory audits.
- Serve as an on-site expert in statistical analysis and problem-solving.
- Plan and execute continuous improvement initiatives on an ongoing basis.
- Manage a team of Quality Engineers and Technicians, providing coaching and mentorship as needed.
Qualifications
- Degree / Diploma qualification in Engineering, Science and/or Quality or relevant experience in a quality assurance role within the Medical Device Industry.
- A minimum of 7 years’ experience in a similar role.
- Proven track record in leading quality within a medical device manufacturing company.
- Ability to manage quality related projects.
- Proven track record in people management. Must be able to manage a team of up to 8 staff.
- Excellent attention to detail.
- Thorough knowledge of applicable regulatory requirements (ISO 13485, FDA etc.)
- Proven track record in problem solving. 6 sigma qualification (Green Belt of higher).
- Understanding of lean principles. Lean green belt an advantage.
- Excellent communication skills both verbal and written.
- A positive attitude in dealing with people.
- Ability to learn and adapt to various situations.
- Must be able to work under own initiative, with minimum supervision.
For further information on this role please contact Michael Marvin on 0864409255 / sourcing@hero.ie
Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/
Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.
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