Site Quality Head

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.