Coloplast Minneapolis , MN 55415
Coloplast has a new opportunity available for a Sr. Supplier Quality Engineer to join our growing company at our Minneapolis facility while providing assistance to various sites.
About the Department
The Quality Engineering department is responsible for monitoring and maintaining quality compliance and implement supplier improvements. You will support our ongoing supplier base and actively participate in our supplier management program. You will support quality deliverables for projects related to suppliers of finished goods, intermediates and raw materials.
Senior Supplier Quality Engineer responsible for managing all aspects of supplier controls for topical over-the-counter, medical device and cosmetic product lines including;
Supplier audit program
Managing change notification
Incoming inspection sampling plans
Supplier Corrective and Preventive Action (SCAPA) investigations
Perform supplier documentation gap assessment to regulation (i.e. FDA 21 CFR 820, ISO13485)
Implement actions to resolve the identified compliance gaps
Support external audits conducted by regulatory bodies (e.g. FDA, Notified body)
Liaise with Procurement and Supply Chain to build and maintain supplier relationships
Travel up to 10% with regards to various sites
BS degree Engineering, Chemistry, Life Sciences or equivalent
3-5 years' relevant experience in a supplier quality engineering role or 5-8 years of quality engineering experience
Experience in a pharma, biologic or medical device manufacturing environment
Manage quality agreements, SCARs, Supplier auditing
SCAPA or CAPA experience
Manufacturing in FDA regulated environment
Certified Quality Audit, Certified Quality Engineer
Experience managing finished goods contract manufacturing
Experience in process or cost improvement
Lead supplier feedback discussions
Product and process risk management experience
The job information contained herein will apply to the candidate successful in being hired for the position. If interested, please apply today!
Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with very private and personal medical conditions. Employing more than 10,000 people and with products available in more than 100 countries, we are one of the worlds leading medical device companies. We are constantly growing our business and always looking for new ways to move forward we explore, learn and look for new ways of doing things. Curiosity works here.
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