What sets this opportunity apart is the opportunity to lead and influence the future of quality management at the Austin Site for a globally recognized organization. Our passionate team is dedicated to driving improvements and ensuring seamless operations. As the Sr Manager, Quality, you will play a crucial role in our commitment to enhancing customer satisfaction and establishing benchmarks in the industry.
Key Duties and Responsibilities
Support and provide expertise to the Quality Management System (QMS) to successfully implement and exceed goals and targets.
Collaborate with various functions to ensure the quality management system is comprehensive, incorporates standard processes, and aligns with the strategic plan.
Oversee product development responsibilities, including design controls, risk management, document control and record management, and supplier management.
Manage manufacturing responsibilities, including master records, training, process controls, labeling, change control, and CAPA.
Monitor and measure validations, calibrations, customer feedback and complaints, and internal audits.
Report all site quality metrics for monthly and quarterly business reviews, such as Product Complaint rates, Cost of Poor Quality, and CAPA.
Provide quality expertise to business process transfer activities, such as process implementation/validation.
Hire and retain a diverse, highly qualified staff, providing ongoing performance feedback. Set and lead goals aligned with department plans through coaching and mentoring.
Ensure continuous improvement through Practical Process Improvement (PPI) and maintain a quality culture that emphasizes "Right First Time."
Minimum Requirements/Qualifications:
Bachelor of Science Degree in Life Sciences, Engineering, or related science/engineering degree preferred.
10+ years of professional quality experience, with quality leadership experience preferred.
Understanding of Life Sciences and IVD/Medical Devices industries and required compliance regulations for Genetic Sciences products and processes.
Solid understanding and experience with ISO 9001 and ISO 13485 standards.
Experience in MDSAP, IVD/IVDR, 510K, and GxP requirements preferred.
Ability to travel domestically and internationally up to 15%.
Proven knowledge and experience implementing Design and Process FMEA's, CAPA process, NPI process, Complaints Handling process, and Change Control process.
Desired Qualifications:
Demonstrated leadership as a valued team member and colleague with leaders at all levels.
Experience working and providing customer support, investigations, and relationship management.
Confirmed communication and customer leadership skills.
