Government, Regulatory and Code, Healthcare, Quality, Quality Engineering
4 Year Degree
This position will be responsible for the development and maintenance of a NVLAP/ISO17025 accredited QMS (Quality Management System) for a new department in the Field and Safety Instruments business unit. This includes the creation and ownership of all SOPs/Work Instructions/Forms, and the development of controlled processes to ensure compliant operations of a testing and calibration lab. This will include the detection of recurring issues, potential corrective actions as well as nonconforming processes relating to design, assembly, materials and testing. This position is hands-on in a manufacturing lab environment which will interact with multiple functions (R&D, Engineering, Operations, Regulatory, and Purchasing).
Lead the laboratory's Quality value stream and related activities
Develop, maintain and be an Authorized Representative for an ISO17025NVLAP accredited Quality Management System (QMS), including all of the procedures and associated processes and records, in close partnership with the NVLAP manager
Lead customer, notified body quality/regulatory, and internal audits at the facility, and the closure of any associated complaints or non-conformances
Analyze critical metrics/data, using statistics, to drive product quality, corrective actions, and reliability improvements
Oversee the change control process for all aspects of the laboratory's service and technical components, ensuring validation processes are fully documented and compliant to the NVLAP standard
Work in a team environment with manufacturing, design engineering, purchasing and suppliers to improve quality while reducing material scrap and cost
Communicate expectations for continuous improvement and realize incremental improvement through the application of quality tools and techniques
Involvement in receiving inspection and MRB activities as related to material issues
Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving issues
Domestic and Global Travel may be required (<10%)
BA/BS degree in Engineering, Quality and/or related technical degree preferred.
Minimum 5 years’ experience in monitoring and resolving quality related product issues in a lab or manufacturing environment
Knowledge of, or ability to rapidly learn, fundamentals of health physics
Expert knowledge in ISO17025 and industry specific standards.
Ability to manage an overall Quality System and its elements
Strong working knowledge of various computer software including MS Excel (pivot tables, charts), MS PowerPoint, MS Project, ERP and MRP queries
Knowledge and experience with FMEAs, DOEs, Process Mapping
Strong oral and written communication skills.
At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.
Apply today! http://jobs.thermofisher.com
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Internal Number: 156381BR
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with annual revenue exceeding $30 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 80,000 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.