• 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.

Job Scope:

The Senior Director, Quality Assurance MDx (Molecular Diagnostics) 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. This position will also provide technical and organizational leadership to Quality Assurance activities for molecular diagnostic manufacturing sites. Partner with Manufacturing, Design/Development, Systems Engineering, Quality Control and others across functions to deliver the highest quality products. This position is responsible for the oversight and control of the Field Quality and Post Market Surveillance, across multiple operational functions inclusive of organizational management, budget preparation, personnel management, organizational goals and metrics, and Executive Level presentations. The Senior Director, Quality Assurance MDx is a leader and a mentor.

Key Responsibilities and Duties

• Ensures that the quality management system demonstrates regulatory compliance per GLP/GCP/cGMP/GXP, ISO, and other applicable regulations for the Luminex sites in Chicago, Madison and Toronto
• Leads global strategy and improvements for the Quality Management System (QMS) for the Licensed Technology Group products (instrument manufacturing) in compliance with regulations and standards.
• Participates and manage activities for external audits such as ISO, FDA or other regulatory bodies for all sites. Acts in Audits - as co-host, SME or escort
• Responds to alleged QMS violations of regulations, policies, procedures as the result of both external and external audits by evaluating and recommending the initiation of investigative activities, immediate corrections and risk analysis processes. Coordinates responses to external audits and manages corrective actions to close.
• Support new product development, provides guidance to the core teams and participates in the Design Control process.
• Interacts with various internal and external groups to facilitate the completion of internal audits, handling of non-conformances, performing Risk Assessments, CAPA, investigation and support, Design validation as well as Design Transfer. QMS improvements and enhancements and is a leading member of the Quality Management Team. Works across the corporation to align and define quality approach for molecular diagnostic products.
• Partners with Site Leadership to conduct, manage, and evaluate investigations related to customer complaints, nonconformances, audits, corrective/preventive action concerns, deviations, recalls, and potential injuries
• Identify and analyze opportunities for continual improvements in product/service quality, customer satisfaction, and company profitability.
• Appropriately escalate Quality issues to the Vice President Quality Assurance and Compliance North America.
• Provide leadership in the application of Quality Tools such as Risk Management, Root Cause Investigations, Designs of Experiments, Capability Studies, in the establishment and investigation of process and products failures and implement lasting solutions of such failures.
• Acts as interim IVDR Person Responsible for Regulatory Compliance (PRRC) for Luminex sites as needed to ensure: the conformity of the devices is appropriately checked before a device is released, the post-market surveillance and reporting obligations are fulfilled and all requirements established between Luminex and Authorized representative are met.
• Act as Interim Management Representative for the site as needed. In this capacity, ensure that product meets label claims and customer satisfaction, any quality or regulatory issue is elevated to the President and/or Vice President Quality Assurance Compliance North America and oversee and drive continuous improvement of the Quality Systems
• Develops and releases Quality Plans and actions to support the changing needs and requirements of the organization as the result of strategic changes in business direction
• Provide other Quality related technical training as necessary
• Directs activities of employees or through managers who exercise full supervision for daily operations. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws.
• Maintains talent through recruiting and development opportunities. Continually develops internal candidates through succession planning and career development.
• Responsible for enforcing all EHS policies in their span of control
• Be part of any the new key and strategic projects and due diligence process if required

QUALIFICATIONS

• Minimum Bachelor degree in a science or engineering discipline with 8+ years of relevant experience/training
• 10+ Years of Experience in Quality Assurance or Regulatory Affairs activities in a cGMP Medical Device or Pharmaceutical environment
• 5+ years of Demonstrated knowledge of current industry quality practices under ISO 13485, ISO 14971, CFR 820 and CFR 806 and international regulations preferred
• 2+ years of Management experience in a complex quality assurance/quality systems field
• 2+ years of 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.
• 5+ years of 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.
• 5+ years of Hands-on ability to sort through technical complexities and work in a flexible changing environment.
• 5+ years of Possesses a strong scientific and technical background, sufficient to establish creditability with senior management as well as the manufacturing and product development teams.

• Excellent interpersonal, verbal and written communication skills
• Thorough knowledge of standards and regulations (cGMP, ISO 13485)
• 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
• Ability to handle the pressure of meeting tight deadlines