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Job Description

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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 Senior Manager, 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 Luminex. The Senior Manager, Quality Assurance will also provide technical and organizational leadership to 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 Senior QA Manager is a leader and a mentor. Key Responsibilities and Duties * Manages, leads and mentors Quality Assurance department and personnel * Site Management Representative - liaison between staff and top management, assure maintenance and effectiveness of quality system and operation, ensure certification remains intact, escort for external audits * Promotes, mentors and coaches staff for growth * QA lead in Risk Management activities, including responses to complaints and recalls * Quality lead in product development team meetings, technical design reviews, and phase gate design review meetings to ensure quality assurance requirements are met. * Integral member of new product development teams. Responsible for ensuring compliance during the design control and design transfer process * Regularly 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 organization * Responds to identified and potential nonconformities, complaints, deviations, and corrective/preventative actions assigned to Quality Assurance * Participates in Audits - internal and external, as SME or escort * Key member of Review Boards as per Quality processes (e.g., MRB, CRT, ORB, SRB) * Responsible for all aspects of regulatory compliance and regulations * Acts of Management Representative for the site. In this capacity, ensure the product meets label claims and customer satisfaction, any quality or regulatory issue is escalated to the Vice President, Quality Assurance and/or DiaSorin S.p.A Head of Corporate Quality/Regulatory, and oversee and drive continuous improvement of Quality Systems * IVDR Person Responsible for Regulatory Compliance (PRRC), the main responsibilities are as detailed in Article 15 of the EU IVDR 2017/746. Includes the conformity of the device is appropriately checked, all requirements with Authorized representative are met and any post market surveillance and reporting activities are fulfilled. QUALIFICATIONS * Bachelor degree required, in a life science/engineering discipline preferred or minimum 8 years' work experience in a regulated / medical device industry required * Masters degree preferred, in a life science/engineering discipline * 1+ years Demonstrated knowledge of current industry quality practices under ISO 13485, ISO 14971 preferred * 1+ years Management experience in a complex quality assurance/quality systems field * Ability 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 issues. * Hands-on ability to sort through technical complexities and work in a flexible changing environment. * Excellent interpersonal, verbal and written communication skills * Thorough knowledge of standards and regulations (cGMP, ISO 13485) * Certification in a quality discipline preferred, such as CQM, CQA * Highly organized with proven time management and prioritization skills * Ability to work independently and with minimal supervision * High degree of problem solving, attention to detail, and analytical skills. * Experience working independently in a fast-paced environment with rapidly changing priorities 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. Nearest Major Market: Austin

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