Director Quality Assurance

Diasorin•Austin, TX

12h

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-system standards and regulations for commercial medical devices designed, produced, and marketed by Luminex. The role partners across 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. The position guides site and corporate quality strategy, regulatory compliance, audits, investigations, corrective actions, and continual improvement. It may serve as the IVDR Person Responsible for Regulatory Compliance (PRRC) for Luminex sites and as the site's Management Representative. The role directs employees directly or through managers, develops talent and succession plans, enforces applicable EHS policies, and supports strategic projects and due diligence. Site activities and documentation must align with corporate procedures and DiaSorin governance requirements.

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 compliance awareness, quality-system ownership, self-regulation, responsiveness, and continuous improvement.
At least 5 years of experience applying industry-accepted problem-solving concepts and tools to complex compliance issues.
At least 5 years of hands-on ability to address technical complexities and work 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.
Experience working independently in a fast-paced environment with rapidly changing priorities.
Ability to handle the pressure of meeting tight deadlines.

Nice To Haves

Demonstrated 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 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.
Lead process optimization and identify opportunities to improve product and service quality, customer satisfaction, and company profitability.
Lead strategy and improvements for instrument manufacturing and the service depot in compliance with regulations and standards.
Participate in and manage external audits, including ISO and FDA or other regulatory-body audits; act 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.
Coordinate internal audits, nonconformance handling, risk assessments, CAPA, investigations, manufacturing validation, and Design Transfer with internal and external groups.
Lead QMS improvements and enhancements and participate as a leading member of the Quality Management Team.
Work across the corporation to align and define the quality approach for molecular diagnostic products.
Partner with Site Leadership and Field Quality to conduct, manage, and evaluate investigations involving customer complaints, nonconformances, audits, corrective/preventive action concerns, 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 act 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 between Luminex and its Authorized Representative.
May act as Management Representative for the site, ensuring products meet label claims and customer expectations, quality or regulatory issues are elevated to the President and/or Vice President Quality Assurance Compliance North America, and continuous improvement is driven.
Develop and release change plans and actions to support changing organizational needs resulting from strategic business changes.
Provide other quality-related technical training as necessary.
Direct employee activities, directly or through managers, with responsibility for daily operations and supervisory responsibilities under 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 key strategic projects and due diligence as required.
Ensure site-level activities and documentation align with corporate procedures and DiaSorin's Corporate and Quality Assurance governance requirements.