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Associate Supplier Quality Engineer

Location: 

N. Mankato, US

Job Family:  Quality Assurance
Country/Region:  United States

Associate Supplier Quality Engineer 

Coloplast has an exciting opportunity for an Associate Supplier Quality Engineerr to join our growing team!

 

The Associate Supplier Quality Engineer is responsible for supporting management of the supplier control functions to produce efficient operation and effective product quality. 

 

Major Areas of Accountability:

  • Responsible for managing aspects of supplier controls for topical over-the-counter, medical device and cosmetic product lines including;
  • Supplier audit program maintenance
  • Quality agreement maintenance
  • Change notification support
  • Incoming inspection sampling and control planning
  • Support of Supplier NCs and Supplier Corrective and Preventive Action (i.e. SCAR) investigation
  • May support external audits conducted by regulatory bodies (e.g. FDA, Notified body, etc.)
  • Liaise with Sr. Supplier Quality Engineer, Procurement and Supply Chain to maintain supplier relationships and high-quality materials received from suppliers
  • Support Supplier Corrective Acton and Preventive Action (i.e. SCAR). May lead investigation team.
  • Initiate supplier related Nonconformance records (NC)
  • Work with Sr. Supplier Quality Engineer, Engineering and Operations to improve supplied material quality to improve production efficiency and finished good quality.
  • Support and/or lead supplier audits.

 

Essential Qualifications:

  • Required:
    • BS degree Engineering, Chemistry, Life Sciences
    • 0-2 years’ relevant experience in a supplier quality engineering role, quality engineering or incoming inspection/testing experience
    • Experience working in a pharmaceutical, biologic or medical device manufacturing environment
    • Product and/or laboratory investigation experience
    • Manufacturing in a highly regulated environment (i.e. FDA, Health Canada, etc.)
  • Preferred: 
    • Experience working with component/raw material or finished good contract manufacturing
    • Experience in process and/or cost improvement
    • SCAR and/or nonconforming material management experience

Required Knowledge, Skills and Abilities:

  • Influence without direct authority
  • Collaborate
  • Sense of urgency while conveying clear, concise communication
  • Work independently with some supervision
  • Proficient in MS Outlook, Excel, and PowerPoint
  • Travel up to 10%

 

 

Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 12,000 people and with products available in more than 143 countries, we are one of the world´s 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.

 

Visit us on Coloplast.com.

Watch the film. Follow us on LinkedIn. Like us on Facebook.

 

Coloplast is committed to a policy of Equal Employment Opportunity (EEO) which means we employ and promote individuals based on their merits, regardless of race, color, religion, sex, national origin, age, disability, veteran status, pregnancy, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status, status with regards to public assistance or any other protected classification.

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