Supplier Quality Engineer

The Interventional Urology 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 work with new product development teams to establish new suppliers and facilitate supplier validations.

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 including new product development.
• 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.
• Coloplast employees are required to conduct business to the highest ethical and professional standards; comply with applicable laws and regulations, the Advamed Code of Ethics on Interactions with Healthcare Professionals, and company policies.

Basic Qualifications

• Bachelor's degree in a relevant science or engineering discipline.
• 2 years of related experience in supplier management.
• 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%.

Competencies

• 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.

At Coloplast, we believe in recognizing and rewarding the contributions of our employees. Our total rewards package is designed to support your well-being, foster your professional growth, and ensure a healthy work-life balance. Here is some of what you can expect:

• 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 and inclusive work environment where everyone feels valued, and diversity is celebrated. Participate in team-building activities, volunteer opportunities, and company-sponsored events. Employee Resource Groups that support Women, Minorities, Veterans and LGBTQ Community. Sustainability strategy that outlines our ambitions for how to run our company in a more sustainable way.
• Competitive Compensation: The compensation range for this position is $82,049- $123,073.Actual compensation is influenced by a variety of factors including but not limited to skills, experience, qualifications, and geographic location. Hired candidates may be eligible to receive additional compensation in the form of bonuses and/or incentives.