Kerecis Limited
Quality Assurance Specialist
Kerecis Limited, Minneapolis, Minnesota, United States, 55400
DescriptionThe Quality Assurance Specialist supports the project teams during the development process of new products and supports existing products when necessary. They are required to comply with Good Manufacturing Practices, ISO requirements, and other recognized standards.The Quality Assurance Specialist is based in a Kerecis office and reports to the Senior Manager Quality Assurance.Essential Functions:
Attains and maintains proficiency in the Company Critical Quality RequirementsAssists in the development, maintenance, and implementation of processes and procedures in accordance with regulatory requirementsMonitors, maintains, and assists with standards for validation, sterilization, risk management, and design activitiesAssists with product return procedures and associated trainingAssists with the resolution and documentation associated with customer complaintsConducts local vendor auditsParticipates and leads teams in Quality decisions and practicesOther tasks and responsibilities as assignedRequirements
Competencies
ASQ CQE or other certifications preferredAbility to work within the team as an individual contributor in a fast paced, changing environmentAdvanced computer skills including statistical/data analysis and report writingDetailed knowledge of FDA, cGMP ISO 13485, and ISO 14971Works with cross functional teams to complete assigned tasksSkill and ability to think analytically by solving problems to make decisions.Strong communication skills (oral and written), with excellent presentation techniqueSelf-motivated problem-solver / trouble-shooter with a strong bias for actionDemonstrated ability to lead technically driven projectsAbility to interact with multidisciplinary colleagues in a team environmentAbility to motivate and guide others to meet objectives and drive actions to closureInnovative thinker, creative, willing to challenge established thinkingFlexibility and adaptability in response to rapidly changing prioritiesAbility to collaborate in a cross-functional and external environmentComfortable coordinating with vendors by phone and emailStrong work ethic to deliver high-quality products on time and within budgetProficient organizational, record keeping skillsProficiency in Microsoft Office suiteEducation & Experience:
BS in Engineering or Technical Field, advanced degree preferred5+ years of medical device experienceTravel: 5%
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Attains and maintains proficiency in the Company Critical Quality RequirementsAssists in the development, maintenance, and implementation of processes and procedures in accordance with regulatory requirementsMonitors, maintains, and assists with standards for validation, sterilization, risk management, and design activitiesAssists with product return procedures and associated trainingAssists with the resolution and documentation associated with customer complaintsConducts local vendor auditsParticipates and leads teams in Quality decisions and practicesOther tasks and responsibilities as assignedRequirements
Competencies
ASQ CQE or other certifications preferredAbility to work within the team as an individual contributor in a fast paced, changing environmentAdvanced computer skills including statistical/data analysis and report writingDetailed knowledge of FDA, cGMP ISO 13485, and ISO 14971Works with cross functional teams to complete assigned tasksSkill and ability to think analytically by solving problems to make decisions.Strong communication skills (oral and written), with excellent presentation techniqueSelf-motivated problem-solver / trouble-shooter with a strong bias for actionDemonstrated ability to lead technically driven projectsAbility to interact with multidisciplinary colleagues in a team environmentAbility to motivate and guide others to meet objectives and drive actions to closureInnovative thinker, creative, willing to challenge established thinkingFlexibility and adaptability in response to rapidly changing prioritiesAbility to collaborate in a cross-functional and external environmentComfortable coordinating with vendors by phone and emailStrong work ethic to deliver high-quality products on time and within budgetProficient organizational, record keeping skillsProficiency in Microsoft Office suiteEducation & Experience:
BS in Engineering or Technical Field, advanced degree preferred5+ years of medical device experienceTravel: 5%
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