Principal Quality Compliance Specialist

This position is responsible for supporting Quality System compliance activities and is responsible for leading and executing the HHE program for the IU B/U. This position is also responsible for contributing to the success of IU ID's Internal and External Audit programs, including facilitation and audit responses. This position directly contributes to the efficiency of the Quality Assurance team by supporting all Quality Assurance functions, building and maintaining strong cross-functional relationships and ensuring conformance to applicable MDR, QS, and other quality requirements.

Major Areas of Accountability

• HHE
  
  
  
  • Local process Owner (LPO) for HHE for the IU B/U, ensuring continuous improvement, efficiency and compliance with internal and external requirements
  • Manage and oversee HHE content creation and compilation, liaising cross-functionally to ensure accuracy and alignment
  • Train and guide users and stakeholders in the implementation of the HHE process and procedures and perform local training as needed; ensure alignment between corporate and local procedures
  • Collaborate and advise HRC and Regulatory team to support recall/field action decision-making
  • Ability to professionally and thoroughly present HHE content and data to support HRC in understanding the risk and extent of field issues for decision-making and execution of internal and external action
  
  
  
  
• Quality Compliance
  
  
  
  • Lead and/or support Quality harmonization, optimization and improvement projects
  • Draft and maintain quality plans, including controlled templates and liaising with cross functional teams to ensure plan implementation and closure
  • Support Post Market activities, as needed, including complaint intake, investigation, and trending
  • Support the CAPA process as needed, including managing CAPAs and ensuring timely completion, providing support during investigation, contributing to determination of corrective and preventive actions, implementation strategy, and determining statistical based verification of effectiveness criteria, where applicable
  • Support CAPA Review Board facilitation, as needed, driving execution and escalation
  • Support Configuration Management and Quality System Training activities, as needed, including change control and direct/indirect labor training
  • Monitor and enhance quality metrics, as needed; execute actions in response to signals
  • Support the organization and facilitation (front and back room) of FDA and Notified Body audits and inspections, as needed
  • Support Management Review, as directed
  • Partner with Regulatory to execute compliance related strategies, as directed
  • Partner with technical teams to ensure quality system enables success while maintaining compliance
  • Support implementation of corporate strategic initiatives at site level, as directed
  
  
  
  

• General
  
  
  
  • Support production to maintain commercial supply and quickly respond to emerging issues; enable efficient review and update of new product and component documentation.
  • 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.
  • Other job duties as assigned
  
  
  
  

Basic Qualifications

• Bachelor's degree in a life science, engineering or other technical discipline
• 6+ years of experience with a medical device manufacturer - Class III experience preferred
• Familiarity with FDA, ISO 13485, MDD, EU MDR, CMDR and related quality system regulations
• Expansive knowledge of regulatory and quality requirements for HHE's, risk management, and recall/field actions
• Experience leading or participating in FDA inspections and ISO registrar audits
• Internal quality auditor experience (ASQ certification desired)
• Ability to methodically analyze data and identify trends
• Excellent communication (verbal and written) and interpersonal skills
• Ability to work independently and in a team environment.
• Personifies Coloplast Mission, Vision and Values
• Ability to travel up to 10%

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 $94,895 - $142,343. 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.

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

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.

59523
#LI-CO #LI-REMOTE