Coloplast

Senior Supplier Quality Engineer

Coloplast

full-time

Posted on:

Location Type: Office

Location: Minneapolis • Minnesota • United States

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Salary

💰 $115,876 - $173,813 per year

Job Level

Senior

About the role

  • Support our ongoing supplier base and actively participate in our supplier management program.
  • Responsible for supporting quality deliverables for projects related to suppliers of finished goods, intermediates, and raw materials.
  • Monitor and maintain quality compliance and implement supplier improvements.
  • 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.
Benefits
  • Comprehensive medical, dental, and vision insurance plans to keep you and your family healthy.
  • 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.
  • A competitive 401(k) plan with company match that vest immediately.
  • Financial planning services to help you secure your future.
  • Corporate discount programs for goods and services.
  • Generous paid time off, flexible work hours, and 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 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.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
supplier managementquality engineeringFDA complianceISO standardsmedical device manufacturingprocess validationsamplingstatisticsLean six-sigmaauditing
Soft Skills
analytical problem-solvingjudgmentcommunicationcollaborationcontinuous improvement
Certifications
Lead Auditor Certification