Associate Director, Product Quality

Position Summary.

The Associate Director, Product Quality, will be responsible for overseeing all aspects of quality control (QC) and product quality assurance (QA) within the organization. Reporting to the Vice President of Quality Assurance and Regulatory Affairs, this leadership position requires a strong understanding of quality tools, quality control processes, and a commitment to maintaining excellence in product quality.

Essential Duties and Responsibilities.

• Develop and implement the company's quality control and product quality strategies, ensuring alignment with industry best practices and business objectives.
• Serve as a technical leader and oversee the implementation and maintenance of a robust product quality systems, including manufacturing processes, quality control, validations, nonconformances and supplier quality.
• Manage the QC and Product QA teams, providing guidance, mentoring, and support to ensure high performance and adherence to quality standards.
• Lead and coordinate quality control activities, including the inspection, testing, and release of raw materials, components, and finished products.
• Establish and monitor quality control metrics and key performance indicators (KPIs) to drive continuous improvement in product quality and operational efficiency.
• Collaborate with cross-functional teams, including R&D, Manufacturing, Regulatory Affairs and other Quality functions, to ensure quality requirements are effectively communicated and incorporated into product design, development, and manufacturing processes.
• Support external audits and inspections conducted by regulatory authorities or third-party organizations.
• Facilitate investigations and resolution of product quality issues, non-conformances, and customer complaints, participating in corrective and preventive actions (CAPAs) as necessary.
• Monitor and analyze quality data, trends, and metrics to identify areas for improvement and proactively address potential quality risks.
• Stay updated on industry regulations, standards, and best practices, ensuring compliance with applicable quality and safety requirements.
• Collaborate with suppliers and contract manufacturers to ensure their adherence to quality standards and requirements.

Education, Qualifications, and/or Experience.

• Bachelor's degree in a scientific or engineering discipline or related field.
• 8+ years of experience in development, manufacturing, validation or quality roles within the medical device or diagnostics industry.
• Strong knowledge of quality management systems, quality control processes, and relevant regulations and standards (e.g., ISO 13485, FDA QSR).
• Demonstrated experience in leading, managing and/or mentoring teams and individuals in a quality function.
• In-depth understanding of quality control methodologies, statistical techniques, and quality tools.
• Experience with quality system audits and inspections by regulatory authorities.
• Strong analytical and problem-solving skills, with the ability to effectively evaluate and resolve quality issues.
• Excellent communication and interpersonal skills, with the ability to collaborate with cross-functional teams and stakeholders.
• Strong project management skills, with the ability to prioritize and manage multiple tasks simultaneously.
• Attention to detail and a commitment to delivering high-quality results.
• Strong leadership and mentoring abilities, with a focus on developing and motivating team members.
• Knowledge of Lean Six Sigma and continuous improvement methodologies is a plus.

Physical Requirements.

• Repetitive Motion: Mostly computer use
• Weight Lifting: < 25 lbs
• Position: Mostly sitting
• Speaking and communicating
• Occasional use of PPE may be required in laboratory/manufacturing/warehouse areas

*THIS ROLE IS 100% ON SITE IN AUSTIN, TX - LOCAL CANDIDATES ONLY - NO SPONSORSHIP IS OFFERED AT THIS TIME*