Director Quality Assurance

DiaSorin • Austin, TX

1d

About The Position

The Director, Quality Assurance for Austin leads, establishes, implements, and maintains quality assurance systems and activities to ensure compliance with domestic and international quality standards and regulations for commercial medical devices designed, produced, and marketed by Luminex. The role partners with Manufacturing, Design/Development, Systems Engineering, Quality Control, and other functions to deliver high-quality instruments and reagents. It oversees product control and release, quality organization management, budget preparation, personnel management, organizational goals and metrics, and executive-level presentations. The Director is also a leader and mentor.

This position provides site-level quality leadership, supports product development and manufacturing changes, leads process and quality-system improvements, manages audits and investigations, and works across the corporation to align quality approaches for molecular diagnostic products. It oversees employees directly or through managers, develops talent and succession plans, enforces EHS policies within its span of control, and ensures site activities and documentation align with corporate procedures and quality governance.

Requirements

• Bachelor's degree in a science or engineering discipline.
• At least 8 years of relevant experience or training.
• At least 10 years of experience in Quality Assurance or Regulatory Affairs in a cGMP medical device or pharmaceutical environment.
• At least 2 years of management experience in a complex quality assurance or quality systems field.
• At least 2 years of demonstrated ability to lead through influence, innovative practices, and coaching to foster responsiveness, compliance awareness, self-regulation, quality-system ownership, constructive challenge, and continuous improvement.
• At least 5 years of experience using industry-accepted problem-solving methodologies and tools to resolve complex compliance issues.
• At least 5 years of hands-on experience addressing technical complexities in a flexible, changing environment.
• At least 5 years of experience demonstrating a strong scientific and technical background sufficient to establish credibility with senior management, manufacturing, and product development teams.
• Excellent interpersonal, verbal, and written communication skills.
• Thorough knowledge of standards and regulations, including cGMP and ISO 13485.
• Strong organization, time-management, and prioritization skills.
• Ability to work independently with minimal supervision.
• Strong problem-solving, attention-to-detail, and analytical skills.
• Ability to work independently in a fast-paced environment with rapidly changing priorities.
• Ability to handle pressure and meet tight deadlines.

Nice To Haves

• Knowledge of current industry quality practices under ISO 13485, ISO 14971, CFR 820, CFR 806, and international regulations is preferred.

Responsibilities

• Ensure the Austin site demonstrates regulatory compliance with GLP/GCP/cGMP/GXP, ISO, and other applicable regulations.
• Support instrument new product development and manufacturing changes by guiding and participating in core teams.
• Identify and analyze opportunities to improve product and service quality, customer satisfaction, and company profitability.
• Lead strategy and improvements for instrument manufacturing and service depots in compliance with regulations and standards.
• Manage and participate in external audits, including ISO and FDA or other regulatory-body audits, serving as co-host, subject matter expert, or escort.
• Evaluate alleged QMS violations and recommend investigations, immediate corrections, and risk analyses; coordinate external audit responses and manage corrective actions through closure.
• Facilitate internal audits, nonconformance handling, risk assessments, CAPA, investigations, manufacturing validation, and Design Transfer with internal and external groups.
• Lead QMS improvements and serve as a leading member of the Quality Management Team; collaborate across the corporation to align quality approaches for molecular diagnostic products.
• Partner with Site Leadership and Field Quality to conduct, manage, and evaluate investigations involving customer complaints, nonconformances, audits, corrective and preventive actions, deviations, recalls, and potential injuries.
• Escalate Quality issues appropriately to the Vice President Quality Assurance Molecular Division.
• Apply Quality Tools, including Risk Management, Root Cause Investigations, Designs of Experiments, and Capability Studies, to investigate process and product failures and implement lasting solutions.
• May serve as IVDR Person Responsible for Regulatory Compliance (PRRC), ensuring device conformity checks before release, fulfillment of post-market surveillance and reporting obligations, and compliance with requirements agreed between Luminex and its Authorized Representative.
• May act as the site Management Representative, ensuring products meet label claims and customer satisfaction, escalating quality or regulatory issues to the President and/or Vice President Quality Assurance Compliance North America, and driving continuous improvement.
• Develop and release Change Plans and actions to support changing organizational needs resulting from strategic business-direction changes.
• Provide quality-related technical training as needed.
• Direct employees, directly or through managers, and supervise daily operations in accordance with organizational policies and applicable laws.
• Recruit and develop talent, including internal candidates through succession planning and career development.
• Enforce EHS policies within the role's span of control.
• Participate in new key and strategic projects and due diligence processes when required.
• Ensure site activities and related documentation align with corporate procedures and DiaSorin's corporate and Quality Assurance governance requirements.

Benefits

• Competitive rewards package focused on overall well-being.
• Health benefits.
• Retirement and financial well-being programs.
• Time-off programs.
• Well-being support and perks.
• Possible eligibility to participate in an annual incentive program, with any award dependent on individual and organizational performance.

What This Job Offers

• Job Type: Full-time
• Career Level: Director