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."
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.
- 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.
Thermo Fisher Scientific
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