Description
Fortune 500 medical technologies firm based in Cork is seeking a Global Supplier Quality Auditor to join their team within their brand new state of the art manufacturing facility in Cork.About the Company
This award winning company has a huge presence in Ireland. It is an exciting growth phase for this organisation and there are presently major expansion operations underway. Being part of this organisation at this time will provide you with a sense of achievement and opportunity to really make an impact.
About the Role
Working in partnership with the Global Supplier Network, you are responsible for the planning, leading, execution and post-processing of supplier QMS and process audits. You perform supplier quality audits in accordance to 21CFR 820, ISO 13485, and other applicable standards to assess and ensure compliance accordance to manufacturing process and product specifications. Moreover, you develop the audit process, procedures and checklists as regulatory requirements change or as a result of continuous audit process improvement. You identify issues that may impact product quality, system gaps or business continuity and ensure these issues are effectively and promptly contained and addressed. You lead pre- and post-audit activities by involving all relevant stakeholders of different functions within global teams. You will have a supporting role to close effectively and timely nonconformities cited during supplier audits.
Requirements
- You have a Bachelor's Degree in medical or mechanical engineering or in a similar field and a minimum of 3 years' audit experience in a regulated manufacturing environment.
- You have a strong working knowledge of QMS and process audits and you are familiar with GMP, ISO 13485, 17025 and 21 CFR Part 820 standards.
- You dispose of a Lead Quality Auditor Qualification/Certification in ISO13485 or comparable industry standards and regulatory requirements.
- You have excellent communication skills and you are characterized by a high motivation and ability to build close relationships internally and externally. Additionally, you are able to plan, organize and implement multiple concurrent tasks.
- You are a goal-oriented individual that is able to effectively work both independently and collaboratively.
- A willingness to travel in support of business needs to different geographical locations.
- You are fluent in English. A very good command of German or French is highly desirable.
Become part of a successful team!
Flat hierarchies, responsibility, and promoting the talents of each individual - that is the basis of the team's philosophy. You will benefit from the advantages of an innovative and employee-oriented business culture. Moreover, you will be offered a wide variety of options that advance your individual professional development. Build your career in an international environment at one of the global leaders in medical technology.
Are looking for a new challenge? A chance to join a thriving global company that continues to go from strength to strength? This is the role the role for you! Please apply below with an up to date CV.
No CV? Not Sure Yet? Give me call for more info and an opportunity to ask more questions Barry Smyth !