Loading...
Apply now »

Senior Supplier Quality Engineer

Location: 

Minneapolis, US

Job Family:  Quality Assurance
Country/Region:  United States

Senior Supplier Quality Engineer 

Coloplast has an exciting opportunity for a Sr. Supplier Quality Engineer to join our growing team!
 

The Interventional Urology Sr. Supplier Quality Engineer will support our ongoing supplier base and actively participate in our supplier management program. You will also be responsible for supporting quality deliverables for projects related to suppliers of finished goods, intermediates, and raw materials. In addition, you will monitor and maintain quality compliance and implement supplier improvements.

In all actions, demonstrate a primary commitment to patient safety and product quality.

 

Major Areas of Accountability

  • Provide direct quality engineering support and strategic solutions to the supply chain to ensure quality compliance, FDA/ISO compliance and issue resolution; act as the supplier quality subject matter expert (SME) in appropriate projects.
  • Manage the Supplier Quality Audit program; includes performing audits or coordinating an outside firm to perform the audits, maintain the Supplier Quality Audit schedule and audit-related records/documents. 
  • Act as internal interface/liaison and partner to Corporate Procurement.
  • Active participation in Material Review Board meetings.
  • Initiate and update Supplier Quality Agreements and component/assembly specifications.
  • Recommend and implement quality improvements of product and processes to promote continuous improvement at suppliers and contract manufacturers.
  • Initiate supplier investigation requests and assist in root cause investigations for supplier related issues. 
  • Facilitate work with Suppliers on Supplier Corrective Action Requests (SCARs)
  • Participate in product and process risk management activities.
  • Participate in Corrective and Preventive Actions as appropriate.
  • Review and approve validation protocols and reports for contract manufacturers and suppliers.
  • Initiate Change Requests to update documentation and Supplier Change Notifications.
  • Cross-training with others in the Quality Team.
  • Other duties as assigned.

 

Essential Qualifications

  • Bachelor's degree in a relevant science or engineering discipline.
  • 5+ year of related experience in supplier management.
  • 2+ years of experience in medical device manufacturing.
  • Experience in medical device process and product validation, sampling, and statistics (e.g. DOE, process analysis/capability, Minitab, and repeatability and reproducibility) highly preferred.
  • Able to travel up to 10%.

 

Required Knowledge, Skills and Abilities

  • Knowledge of FDA regulations (21 CFR Part 820) and ISO standards (13485, 14971) and their application.
  • Ability to apply standard techniques, procedures, and criteria to perform assigned tasks. 
  • Exercises judgment on details of work and able to demonstrate knowledge and developing skills in the supplier quality function.
  • Analytical problem-solving skills.
  • Experience with continuous improvement, Lean six-sigma, or similar programs and techniques.
  • Familiarity with Supplier Scorecards and Management techniques highly preferred.
  • Prior experience as an auditor for both suppliers and internal audits highly preferred.
  • Lead Auditor Certification highly preferred
  • Personifies and fosters the Coloplast Mission, Vision and Values.

 

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.

51055
#LI-CO


Nearest Major Market: Minneapolis

Apply now »