Coloplast · 1 hour ago
Principal Quality Compliance Specialist
Minneapolis, MN
Full-time
Onsite
Senior Level, Lead/Staff
$95K/yr - $142K/yr
6+ years expColoplast is a leading medical device company that develops and markets products and services for intimate healthcare needs. They are seeking a Principal Quality Compliance Specialist to support Quality System compliance activities and contribute to the success of Internal and External Audit programs while ensuring conformance to applicable quality requirements.
Health CareManufacturingMedical Device
Responsibilities
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
Qualification
Required
Bachelor's degree in a life science, engineering or other technical discipline
6+ years of experience with a medical device manufacturer
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%
Internal quality auditor experience
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
Preferred
Class III experience preferred
ASQ certification desired
Benefits
Comprehensive medical, dental, and vision insurance plans to keep you and your family healthy.
Access to company sponsored wellness programs and mental health resources.
Paid leave of absence for qualifying events.
Generous paid parental leave for both birthing and non-birthing parents.
A competitive 401(k) plan with company match that vest immediately.
Financial planning services to help you secure your future.
Corporate discount programs for goods and services.
Generous paid time off.
Flexible work hours.
Flexible work arrangement options to help you balance your personal and professional life may be available.
Opportunities for continuous learning and career advancement through training programs, mentorship, and tuition reimbursement.
Recognition programs to celebrate achievements and contributions, including peer recognition, bonuses, awards, and special events.
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.
Company
Coloplast
Coloplast is a manufacturer of medical devices that offers ostomy, continence, and wound care products.
10001+ employees
H1B Sponsorship
Coloplast has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (1)
2022 (2)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
$1.34B2023-08-29Post Ipo Equity· $1.34B
2000-02-04IPO
Leadership Team
Lars Rasmussen
Chairman of the Board of Directors
Recent News
Essential Business
2025-12-20
2025-12-18
2025-12-05
Company data provided by crunchbase