DiaSorin
Quality Assurance Supervisor
DiaSorin, Saint Paul, Minnesota, United States,
Quality Assurance Supervisor
Published on: Aug 8, 2024Country: United StatesLocation: ChicagoCompany: Luminex CorporationJob Category: QualityEmployment type: Regular Full TimeJob Scope:The Supervisor, Quality Assurance will lead, establish, implement and maintain quality assurance systems and activities ensuring compliance with domestic and international quality system standards and regulations for commercial medical devices designed, produced and marketed by DiaSorin Molecular. The Supervisor, Quality Assurance will also provide technical and operational leadership for Quality Assurance activities, Quality System development and implementation, validations and process development, design change, corrective and preventive action, change control, and quality audits and partner with Manufacturing, Design/Development, Systems Engineering, Quality Control and others across functions to deliver the highest quality products. The QA Supervisor is a leader and a mentor for their direct reports.Key Responsibilities and Duties:Manages, leads and mentors Quality Assurance department and personnelPromotes, mentors and coaches staff for growthQA lead in Risk Management activities, including responses to complaints and recallsQuality lead in production team meetings and on-market product technical reviews to ensure quality assurance requirements are metIntegral member of production teams. Responsible for ensuring compliance during the design transfer and production processRegularly reviews quality system standard operating procedures and work instructions, making changes as necessary to ensure compliant and efficient Quality Assurance processesProvides input to the Management Review and Quality Review Board processes and monitors the Quality Management System (QMS), and provides training throughout the organizationResponds to identified and potential nonconformities, complaints, deviations, and corrective/preventative actions assigned to Quality AssuranceParticipates in Audits – internal and external, as SME or escortKey member of select Review Boards as per Quality processes (e.g., MRB, CRT, ORB, SRB)Responsible for all aspects of QMS complianceEducation, Experience, and Qualifications:Bachelor’s degree in Preferably in a life science/engineering discipline or minimum 5 years’ work experience in a regulated/medical device industry required3+ years Demonstrated knowledge of current industry quality practices under ISO 13485, ISO 149711+ years Management experience in a complex quality assurance/quality systems fieldAbility to provide leadership to others in the organization through influence, innovative practices and coaching skills to foster a corporate culture of responsiveness, compliance awareness, self-regulation, quality system ownership, challenge of status quo, and continuous improvement in order to achieve the highest level of compliancePossesses a strong scientific and technical background, sufficient to establish credibility with senior management as well as the manufacturing and product development teamsExcellent problem solving methodology, using industry accepted concepts and tools to solve complex problems in creative and effective ways as they apply to compliance issuesHands-on ability to sort through technical complexities and work in a flexible changing environmentExcellent interpersonal, verbal and written communication skillsThorough knowledge of standards and regulations (cGMP, ISO 13485)Highly organized with proven time management and prioritization skillsHigh degree of problem solving, attention to detail, and analytical skillsCertification in a quality discipline preferred, such as CQM, CQAAbility to work independently and with minimal supervisionExperience working independently in a fast-paced environment with rapidly changing prioritiesTravel, Local and international travel may be required approximately 10% of the timeWhat we offer:Receive a competitive salary and benefits package as you grow your career at DiaSorin. Join our team and discover how your work can impact the lives of people all over the world.
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Published on: Aug 8, 2024Country: United StatesLocation: ChicagoCompany: Luminex CorporationJob Category: QualityEmployment type: Regular Full TimeJob Scope:The Supervisor, Quality Assurance will lead, establish, implement and maintain quality assurance systems and activities ensuring compliance with domestic and international quality system standards and regulations for commercial medical devices designed, produced and marketed by DiaSorin Molecular. The Supervisor, Quality Assurance will also provide technical and operational leadership for Quality Assurance activities, Quality System development and implementation, validations and process development, design change, corrective and preventive action, change control, and quality audits and partner with Manufacturing, Design/Development, Systems Engineering, Quality Control and others across functions to deliver the highest quality products. The QA Supervisor is a leader and a mentor for their direct reports.Key Responsibilities and Duties:Manages, leads and mentors Quality Assurance department and personnelPromotes, mentors and coaches staff for growthQA lead in Risk Management activities, including responses to complaints and recallsQuality lead in production team meetings and on-market product technical reviews to ensure quality assurance requirements are metIntegral member of production teams. Responsible for ensuring compliance during the design transfer and production processRegularly reviews quality system standard operating procedures and work instructions, making changes as necessary to ensure compliant and efficient Quality Assurance processesProvides input to the Management Review and Quality Review Board processes and monitors the Quality Management System (QMS), and provides training throughout the organizationResponds to identified and potential nonconformities, complaints, deviations, and corrective/preventative actions assigned to Quality AssuranceParticipates in Audits – internal and external, as SME or escortKey member of select Review Boards as per Quality processes (e.g., MRB, CRT, ORB, SRB)Responsible for all aspects of QMS complianceEducation, Experience, and Qualifications:Bachelor’s degree in Preferably in a life science/engineering discipline or minimum 5 years’ work experience in a regulated/medical device industry required3+ years Demonstrated knowledge of current industry quality practices under ISO 13485, ISO 149711+ years Management experience in a complex quality assurance/quality systems fieldAbility to provide leadership to others in the organization through influence, innovative practices and coaching skills to foster a corporate culture of responsiveness, compliance awareness, self-regulation, quality system ownership, challenge of status quo, and continuous improvement in order to achieve the highest level of compliancePossesses a strong scientific and technical background, sufficient to establish credibility with senior management as well as the manufacturing and product development teamsExcellent problem solving methodology, using industry accepted concepts and tools to solve complex problems in creative and effective ways as they apply to compliance issuesHands-on ability to sort through technical complexities and work in a flexible changing environmentExcellent interpersonal, verbal and written communication skillsThorough knowledge of standards and regulations (cGMP, ISO 13485)Highly organized with proven time management and prioritization skillsHigh degree of problem solving, attention to detail, and analytical skillsCertification in a quality discipline preferred, such as CQM, CQAAbility to work independently and with minimal supervisionExperience working independently in a fast-paced environment with rapidly changing prioritiesTravel, Local and international travel may be required approximately 10% of the timeWhat we offer:Receive a competitive salary and benefits package as you grow your career at DiaSorin. Join our team and discover how your work can impact the lives of people all over the world.
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