Site Quality Head at Thermo Fisher Scientific in Austin, Texas

Job Description:

Work Schedule

Standard (Mon-Fri)



Environmental Conditions

Office



Job Description



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."

• 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.

• 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.


• Experience supporting organizational change efforts.


• Demonstrated people leadership skills.


• Personal awareness and desire for continual learning and personal development.


• Hands-on and productive, with minimal instruction required for day-to-day work.


• Strong interpersonal, verbal, and written communications skills are crucial.