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Senior Manager, Quality Assurance

Location: 

Minneapolis, US

Job Family:  Quality Assurance
Country/Region:  United States
Senior Manager, Quality Assurance 

Coloplast has an exciting opportunity for a Quality Assurance Senior Manager to join our growing team!

 

This position manages the Quality Assurance Team based in Minneapolis, which includes systems, configuration management, training teams, and post market.  The focus of this role is to ensure compliance with applicable regulations and corporate requirements, as well as driving quality deliverables.  This leader will be responsible for leading, maintaining, and developing the organization to align with and enable the growth ambitions of the Interventional Urology business unit based in Minneapolis MN.

 

Major Areas of Accountability:

  • Organizational Leadership
    • Develop and deliver on strategies to improve efficiency, effectiveness, and compliance
    • Develop, organize, and direct a team capable of maintaining and improving the Quality System
    • Align and partner with multiple sites, functions, and corporate globally
  • Quality Systems
    • Lead the maintenance, improvement, and compliance of the quality management system
    • Support global activities, align across the business units, and tailor to the local level
    • Create, deploy, and monitor quality metrics – drive action to respond to signals
    • Responsible for external audit organization and execution
    • Serve as Management Representative for the Minneapolis site
  • Configuration Management
    • Optimize multiple systems to improve efficiency, simplicity, and cross-system interactions.
    • Partner with Regulatory to deploy and manage a system to maintain external standards
    • Responsible for administration of the document control system (Veeva)
    • Systems include:  Veeva, Trackwise, PDM, Paper-based, E1
  • Training
    • Responsible for administration of the training systems
    • Ensures cross functional teams are aware and capable of completing training on time
    • System includes:  SuccessFactors, Learnit
  • Post Market
    • Ensure timely processing of complaints and post market surveillance activities
    • Heavily involved in field action assessment, decisions, and execution
  • General
    • Support production to maintain commercial supply and quickly respond to emerging issues; enable efficient review and update of new product and component documentation.
    • Conform with Coloplast Code of Conduct and all local Compliance Standards
    • Conform with Coloplast Q/EHS Policy
    • Other duties as assigned and as the business unit evolves

 

Essential Qualifications:

  • Bachelor's degree from a four-year college or university in a relevant science or engineering discipline
  • 10+ years experience managing multiple teams
  • 15+ years experience in quality
  • 10+ years in medical device industry
  • Experience in medical device documentation, records control, and quality systems.
  • Working knowledge of ISO 13485, 21 CFR Part 820, and EU MDR
  • 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
  • Capable of optimizing systems and processes to maximize efficiency and value, while eliminating waste
  • Effective organizational, management, and communication skills
  • Personifies and fosters the Coloplast Mission, Vision and Values

 

Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 12,000 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.

Watch the film. Follow us on LinkedIn. Like us on Facebook.

 

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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Nearest Major Market: Minneapolis

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