DiaSorin
Quality Assurance Supervisor
DiaSorin, Northbrook, Illinois, us, 60065
Diasorin is a global leader in diagnostic solutions, pushing the boundaries of science and technology to create cutting-edge tools that improve healthcare worldwide. With a legacy spanning over 50 years, we've earned our reputation for excellence by developing innovative diagnostic assays and instruments that are trusted by healthcare providers around the world.Our broad offering of diagnostic tests and Licensed Technology solutions, made available thanks to ongoing investments in research, positions us as the player with the widest range of specialty solutions in the sector and identifies us as the "Diagnostics Specialist."Why Join Diasorin?Impactful Work: When you join Diasorin, you become part of a team that's dedicated to improving lives. Your contributions will directly impact patient care, making a meaningful difference in the world.
Global Reach & Innovation: Our work transcends borders. Joining Diasorin means collaborating with colleagues from all over the world, expanding your horizons, and contributing to global healthcare solutions at the forefront of the diagnostic industry.
Diverse and Inclusive Culture: We believe in the strength of diversity, and our inclusive culture reflects this commitment. We value your unique perspective and offer a supportive, collaborative environment where everyone can thrive.Join Our Team: If you're passionate about innovation, diversity, and making a positive impact on healthcare, Diasorin is the place for you. We're looking for passionate and talented individuals who are ready to embrace new challenges and drive healthcare solutions forward.Are you ready to be part of a dynamic team that's shaping the future of diagnostics? Join Diasorin and become a catalyst for change in the world of healthcare. Apply today and be a part of our exciting journey toward a healthier, more connected world. Together, we can make an impact!Job 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 DutiesManages, leads and mentors Quality Assurance department and personnel
Promotes, 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 met.Integral 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 processes.Provides 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 complianc
Education, Experience, and QualificationsBachelor'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 compliance.Possesses a strong scientific and technical background, sufficient to establish creditability with senior management as well as the manufacturing and product development teams.Excellent 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 environment.Excellent 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 skills.Certification 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 time
WhatweofferReceive 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.Diasorin is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status, and will not be discriminated against on the basis of disability.In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and Canada and to complete the required employment eligibility verification document form upon hire.Diasorin is committed to providing reasonable accommodations for qualified individuals with disabilities. If you are a US or Canada candidate and require assistance or accommodation during the application process, please contact the North America Talent Acquisition Team at hrtalent@diasorin.com or 1-800-328-1482 to request an accommodation.The above job description is intended to describe the general content, identify the essential functions, and set forth the requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or requirements.Diasorin reserves the right to modify or amend this job posting as needed to comply with local laws and regulations.Please note that offers of employment at Diasorin may be contingent upon successful completion of a pre-employment background check and drug screen, subject to applicable laws and regulations.This position is not eligible for partnership with a third-party search firm vendor without expressed, written consent from the Diasorin Human Resources Department.
Global Reach & Innovation: Our work transcends borders. Joining Diasorin means collaborating with colleagues from all over the world, expanding your horizons, and contributing to global healthcare solutions at the forefront of the diagnostic industry.
Diverse and Inclusive Culture: We believe in the strength of diversity, and our inclusive culture reflects this commitment. We value your unique perspective and offer a supportive, collaborative environment where everyone can thrive.Join Our Team: If you're passionate about innovation, diversity, and making a positive impact on healthcare, Diasorin is the place for you. We're looking for passionate and talented individuals who are ready to embrace new challenges and drive healthcare solutions forward.Are you ready to be part of a dynamic team that's shaping the future of diagnostics? Join Diasorin and become a catalyst for change in the world of healthcare. Apply today and be a part of our exciting journey toward a healthier, more connected world. Together, we can make an impact!Job 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 DutiesManages, leads and mentors Quality Assurance department and personnel
Promotes, 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 met.Integral 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 processes.Provides 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 complianc
Education, Experience, and QualificationsBachelor'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 compliance.Possesses a strong scientific and technical background, sufficient to establish creditability with senior management as well as the manufacturing and product development teams.Excellent 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 environment.Excellent 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 skills.Certification 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 time
WhatweofferReceive 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.Diasorin is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status, and will not be discriminated against on the basis of disability.In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and Canada and to complete the required employment eligibility verification document form upon hire.Diasorin is committed to providing reasonable accommodations for qualified individuals with disabilities. If you are a US or Canada candidate and require assistance or accommodation during the application process, please contact the North America Talent Acquisition Team at hrtalent@diasorin.com or 1-800-328-1482 to request an accommodation.The above job description is intended to describe the general content, identify the essential functions, and set forth the requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or requirements.Diasorin reserves the right to modify or amend this job posting as needed to comply with local laws and regulations.Please note that offers of employment at Diasorin may be contingent upon successful completion of a pre-employment background check and drug screen, subject to applicable laws and regulations.This position is not eligible for partnership with a third-party search firm vendor without expressed, written consent from the Diasorin Human Resources Department.