Thermo Fisher Scientific Engineer III, Quality Assurance in Middletown, Virginia
When you join us at Thermo Fisher Scientific, you’ll be part of a smart, driven team that shares your passion for exploration and discovery. With revenues of $22 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.
Thermo Fisher Scientific (NYSE: TMO) is headquartered in Waltham, MA, and is the world leader in serving science, enabling our customers to make the world healthier, cleaner and safer. With annual sales of more than $9 billion, we employ 30,000 people and serve over 350,000 customers within pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions and government agencies, as well as environmental and industrial process control settings. Serving customers through two premier brands, Thermo Scientific and Fisher Scientific, we help solve analytical challenges from routine testing to complex research and discovery. Thermo Scientific offers customers a complete range of high-end analytical instruments as well as laboratory equipment, software, services, consumables and reagents to enable integrated laboratory workflow solutions. Fisher Scientific provides a complete portfolio of laboratory equipment, chemicals, supplies and services used in healthcare, scientific research, safety and education. Together, we offer the most convenient purchasing options to customers and continuously advance our technologies to accelerate the pace of scientific discovery, enhance value for customers and fuel growth for shareholders and employees alike. Visit http://www.thermofisher.com .
What will you do?
Serve as the primary interface between the Value Stream and Quality Assurance
Provide support to the Value Stream in investigating nonconformances, audit findings, CAPA, complaints, environmental alerts and SCARs by conducting risk assessment and root cause analysis and determining corrective actions.
Provide support to Quality Assurance in resolving NCRs and DRs, determining material dispositions, identifying supplier-caused problems and initiating SCARs to suppliers.
Assist in the preparation and approval of COs related to the operation and improvement of the Value Stream processes.
Drive continuous quality improvement in the processes related to the Value Streams. Maintain and monitor appropriate metrics to measure Value Stream quality performance. Determine continuation of the validated process state and initiate revalidation activities as necessary.
Support the Value Stream and Engineering by ensuring manufacturing processes and equipment have sufficient capability to meet customer requirements by analyzing capability studies, control charts and other statistical data.
Ensure equipment used by the Value Stream is properly validated, calibrated, maintained and verified in the calibrated or validated state.
Support development projects, transfer projects, process changes and engineering projects in the Value Stream to provide overall quality assurance as it relates to quality standards, inspection techniques and frequencies, statistical analysis, testing, validations, and risk assessments (FMEAs).
Serve as primary interface with customer quality assurance teams to respond to customer requests for documentation, data, investigations, risk assessments and testing.
Issue customer Change Notifications to customers as necessary based on Supplier Change Notifications or internal engineering and manufacturing projects.
Serve as project manager for small-to-mid scale customer facing projects. Assemble team, conduct meetings, create and maintain milestones and timelines, provide reports and updates to management.
Participate as team member on large scale customer-facing projects providing needed support and expertise to project manager.
Assist in training and maintaining compliance to regulations and procedures.
Other related tasks as assigned by Management.
How will you get here?
Bachelor’s degree in Science or Engineering or related discipline.
ASQ certified engineer and ASQ certified auditor preferred. Six Sigma/Lean certified preferred.
Minimum of 5 years quality experience with a medical device company.
Knowledge of global regulatory and quality requirements associated with medical devices.
Working knowledge of ISO 13485:2003, 21 CFR Part 820, IVD Directive and Canadian MDR.
Experience in formal problem solving in a team environment.
Detail oriented and has the ability to lead multiple projects and activities assigned.
Excellent organizational skills, planning, communication and follow up skills.
Proficient in Microsoft Word and Excel. SAP experience preferred.
Normal office and manufacturing environment.
Position will require frequent communication with and walking to other areas in which designated PPE will be required.
Position will require prolonged sitting and standing.
Employee may occasionally lift and/or move up to 25 pounds.
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
If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here at https://jobs.thermofisher.com/page/show/eeo-affirmative-action-statement#accessibility for further assistance.
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.
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