Principal Quality Compliance Specialist

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This position is responsible for supporting Quality System compliance activities and supporting execution of the HHE program for the IU B/U. This position is also responsible for contributing to the success of IU ’s Internal and External Audit programs. 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.

• 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
• Lead and/or support HHE content creation and compilation, liaising cross-functionally to ensure accuracy and alignment
• Ensure continuous improvement, efficiency and compliance with internal and external requirements
• 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
• 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

• 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
• Experience leading or participating in FDA inspections and ISO registrar audits
• Ability to travel up to 10%

• Ability to methodically analyze data and identify trends
• Excellent communication (verbal and written) and interpersonal skills
• Direct teams by defining clear Objectives (desired result) and associated Key Results (required actions)
• Ability to work independently and in a team environment.
• Personifies 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 $94,895 -…