Senior Supplier Quality Engineer Job at Coloplast (Minneapolis)

Senior Supplier Quality Engineer

Coloplast

Location:
United States , Minneapolis

Category:
Manufacturing

Contract Type:
Not provided

Salary:

115876.00 - 173813.00 USD / Year

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Job Description:

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.

Job Responsibility:

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
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
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.

Requirements:

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%
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.

Nice to have:

Experience in medical device process and product validation, sampling, and statistics (e.g. DOE, process analysis/capability, Minitab, and repeatability and reproducibility) highly preferred
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.

What we offer:

Comprehensive medical, dental, and vision insurance plans
Access to company sponsored wellness programs and mental health resources
Paid leave of absence for qualifying events
Generous paid parental leave for both birthing and non-birthing parents
Competitive 401(k) plan with company match that vest immediately
Financial planning services
Corporate discount programs for goods and services
Generous paid time off
Flexible work hours
Flexible work arrangement options
Opportunities for continuous learning and career advancement through training programs, mentorship, and tuition reimbursement
Recognition programs to celebrate achievements and contributions, including peer recognition, bonuses, awards, and special events
A supportive work environment
Participate in team-building activities, volunteer opportunities, and company-sponsored events
Sustainability strategy.

Additional Information:

Job Posted:
March 13, 2026

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