Coloplast
Principal Quality Compliance Specialist
Coloplast, Minneapolis, Minnesota, United States, 55400
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 duties as assigned and as the business unit evolves.
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.Ability to travel up to 10%.Knowledge, Skills and Abilities: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.
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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 duties as assigned and as the business unit evolves.
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.Ability to travel up to 10%.Knowledge, Skills and Abilities: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.
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