Manager, Quality Engineering

This position manages the supplier quality, operations quality, and design assurance teams – ensuring compliance with applicable regulations and corporate requirements, while driving quality deliverables.  This leader will be responsible for leading, maintaining, and developing the organization in line with the growth of the Interventional Urology business unit based in Minneapolis MN

• Management
  • Lead and the develop the supplier quality, operations quality, and design assurance teams
  • Align and partner with multiple sites and corporate (global)
  • Participate in Material Review Board, risk management activities, and CAPA
  • Review and approve technical documentation
  • Promote continuous improvement through identifying and implementing improvements to supplier controls, product design, manufacturing processes, and quality systems
• Supplier Quality
  • Oversee supplier related project resourcing, budgeting, project scheduling and communication
  • Oversee supplier quality including monitoring, scorecards, audits, quality agreements, SCAR's, validations, and material changes
  • Sets policy and procedure guidelines for supplier quality owned processes
• Operations Quality
  • Support production to maintain commercial supply and quickly respond to emerging issues
  • Oversee non-conformance initiation, execution, management, and escalation
  • Sets policy and procedure guidelines for operations quality owned processes

• General
• Conform with Coloplast Q/EHS Policy
• Coloplast employees are required to conduct business to the highest ethical and professional standards; comply with applicable laws and regulations, the MedTech Code of Conduct, and company policies.
• Other duties as assigned

Basic Qualifications

• Bachelor's degree from a four-year college or university in a relevant science or engineering discipline
• 3+ years experience managing a team of engineers
• 7+ years experience in quality engineering
• 7+ years in medical device industry
• Experience in medical device process validation, design validation, and quality systems.
• Working knowledge of ISO 13485 and 21 CFR Part 820
• Able to travel, both domestic and international up to 15%

Required Knowledge, Skills and Abilities

• Ability to effectively develop, champion, and communicate strategies
• Strategic thinker with methodical problem solving skills and practical application
• Experience with FDA regulations (21 CFR Part 820), ISO standards (13485, 14971), and EU MDR
• Knowledge of statistical methods, lean manufacturing, design controls, and risk management
• Effective organizational, management, and communication skills
• 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 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.
• Competitive Compensation: The compensation range for this position is $115,876 -  $173,813. 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.

Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 16,000 people and with products available in more than 143 countries, we are one of the world´s leading medical device companies. We are constantly growing our business and always looking for new ways to move forward – we explore, learn and look for new ways of doing things.

Visit us on Coloplast.com.

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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.

Coloplast is committed to a policy of Equal Employment Opportunity (EEO) which means we employ and promote individuals based on their merits, regardless of race, color, religion, sex, national origin, age, disability, veteran status, pregnancy, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status, status with regards to public assistance or any other protected classification.

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