Senior Supplier Quality Engineer

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.

• 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.

• Bachelor's degree in a relevant science or engineering discipline.
• 5+ years 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.

• 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 vests 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.…