Principal Quality Compliance Specialist

This position is responsible for supporting Quality System compliance activities and is responsible for leading and executing the CAPA program at the Minneapolis Interventional Urology ID site. This position is also responsible for the Internal Audit schedule and execution and contributing to the success of External Audits including facilitation and audit responses. This position directly contributes to the efficiency of the Quality Assurance team by building and maintaining strong cross-functional relationships and ensuring conformance to applicable MDR, QS, and other quality requirements

Major Areas of Accountability

• Quality Compliance
• Maintain an effective, efficient, and cohesive CAPA and Internal Audit process which ensures compliance with internal and external requirements
• Ensure processes needed for the CAPA and Internal Audit are documented and controlled
• Partner with CAPA owners in cross functional departments to manage CAPAs and ensure timely completion, including providing support during investigation, contributing to determination of corrective and preventive actions, identifying implementation strategy, and determining statistical based verification of effectiveness criteria, where applicable
• Monitor status of active CAPAs – identifying, escalating, and resolving execution risks
• Report on performance of CAPA and Internal Audit processes to site level and management, as applicable
• Optimize and lead the CAPA Review Board – driving execution and escalation, as appropriate
• Monitor and enhance quality metrics – execute actions in response to signals
• Support the organization and facilitation (front and back room) of FDA, Notified Body, and Supplier audits and inspections
• Serve as external audit facilitator and lead appropriate audit responses
• Support Management Review, as directed by the Sr. Quality Assurance Manager
• 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
• Define and execute projects to improve efficiency, effectiveness, and compliance
• Tissue Bank
• Serve as Tissue Bank Director – managing tissue storage area, processes, and training.
• Maintain state licenses and ensure FDA compliance.
• 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
• Experience leading or participating in FDA inspections and ISO registrar audits
• Ability to travel up to 10%     

Knowledge, Skills & Abilities

• Internal quality auditor experience (ASQ certification desired)
• 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 - $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.

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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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