How Will You Make an Impact?

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.

As the Quality Assurance Manager, you will collaborate with cross-functional teams to manage product quality function in overall systems and drive quality initiatives to achieve continual quality improvement objectives

What will you do?

• Manage Product Quality function in overall systems, products and processes to meet quality and relevant regulatory requirements.
• Lead and participate in the development and implementation of quality initiatives to address product, process and system inadequacies to achieve continual quality improvement objectives.
• Provide guidance to Product Quality function in support of plant wide activities, projects and quality initiatives to meet organizational objectives.
• Work with Product Quality function to ensure timely investigation of nonconformance / customer complaints and the implementation of effective corrective actions.
• Participate in monthly CAPA meeting to identify adverse trends in product/quality performance and facilitate the initiation of corrective and preventive actions.
• Support Customer, Regulatory and Corporate Audits.
• Mentor / supervise as assigned and ensure timely and accurate completion of quality projects through PPI initiatives.
• Ensure quality activities are in alignment with company goals, objectives and in compliance with QMS.
• Participate in New Product / Transfer projects, as assigned.

How will you get here?

Education

• Bachelor’s Degree in quality management, Engineering, Science or equivalent.

Experience

• Relevant Medical Device manufacturing experience in an ISO13485 or GMP environment with 5 or more years of managerial experience.

Knowledge, Skills, Abilities

• Ability to manage a diverse team and contribute in a global matrix organization.
• Strong relationship skills and multi-tasking are required.
• Excellent knowledge of Quality Management System primarily in ISO 13485 and FDA 21 CFR Part 820.
• Demonstrate leadership and implement change management.
• Ability to think strategically and creatively.
• Lead, mentor and facilitate problem solving and quality improvements.
• Trained Lead/Internal Auditor in ISO 13485 preferred.