Description
I have an immediate opening for a Global Supplier Quality Auditor with a leading medical device company based in Cork. This is a permanent position and is a very exciting time to be joining the company.Job Description
- 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.
- The position can be located anywhere in Europe.
Your Profile
- 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.
- You are willing to travel up to 70% 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.
If you are interested in hearing more about this excellent opportunity please respond with an updated CV for immediate consideration.