Senior Director Quality Assurance LTG - Austin, TX

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 Director, Quality Assurance Instrument Development and Manufacturing 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 instruments.  This position is responsible for the oversight, control and release of instruments, quality organizational management, budget preparation, personnel management, organizational goals and metrics, and Executive Level presentations.  The Senior Director, Quality Assurance Instruments and Licensed Technology Group is a leader and a mentor.

Key Responsibilities and Duties 

• Ensures that the Austin site demonstrates regulatory compliance per GLP/GCP/cGMP/GXP, ISO, and other applicable regulations.Austin
• Support instrument new product development, provides guidance to the core teams and participates in the Design Control process.
• Leads strategy and improvements for the  development, manufacturing and service depot  of Instruments for our customers and partners in compliance with regulations and standards.
• Participates and manage activities for external audits such as ISO, FDA or other regulatory bodies for the Austin site.  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.
• 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 i IVDR Person Responsible for Regulatory Compliance (PRRC) for Luminex sites 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 Management Representative for the site.  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.
• 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 

What 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.

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.