Coloplast · 21 hours ago
Senior Supplier Quality Engineer
Minneapolis, MN
Full-time
Hybrid
Mid, Senior Level
$116K/yr - $174K/yr
5+ years expColoplast is a leading medical device company that develops and markets products to improve intimate healthcare needs. The Interventional Urology Sr. Supplier Quality Engineer will support supplier management and ensure quality compliance for suppliers of finished goods, intermediates, and raw materials, with a strong focus on patient safety and product quality.
Medical DeviceHealthcareManufacturingHealth Care
Responsibilities
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
Qualification
Required
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
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
Able to travel up to 10%
Preferred
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
Benefits
Health and Wellness : Comprehensive medical, dental, and vision insurance plans to keep you and your family healthy. Plus, access to company sponsored wellness programs and mental health resources, paid leave of absence for qualifying events and generous paid parental leave for both birthing and non-birthing parents.
Financial Security: A competitive 401(k) plan with company match that vest immediately, financial planning services to help you secure your future, and corporate discount programs for goods and services.
Work-Life Balance: Generous paid time off, flexible work hours, and flexible work arrangement options to help you balance your personal and professional life may be available.
Professional Development: Opportunities for continuous learning and career advancement through training programs, mentorship, and tuition reimbursement.
Recognition and Rewards: Recognition programs to celebrate achievements and contributions, including peer recognition, bonuses, awards, and special events.
Community and Culture: A supportive work environment where everyone feels valued, and has a sense of belonging. Participate in team-building activities, volunteer opportunities, and company-sponsored events. Sustainability strategy that outlines our ambitions for how to run our company in a more sustainable way.
Company
Coloplast
Coloplast is a manufacturer of medical devices that offers ostomy, continence, and wound care products.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$1.34B2023-08-29Post Ipo Equity· $1.34B
2014-01-29IPO
Leadership Team
Lars Rasmussen
Chairman of the Board of Directors
Recent News
Essential Business
2025-12-20
2025-12-18
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