Thermo Fisher Scientific R&D Quality Engineer in Logan, Utah
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of $17 billion and 50,000 employees in 50 countries. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity. Our four premier brands - Life Technologies, Thermo Scientific, Fisher Scientific and Unity Lab Services - offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive support. For more information, please visit www.thermofisher.com at http://www.thermofisher.com/ .
The Design Compliance Quality Engineer will be responsible for supporting the New Product Introduction (NPI) by providing input to the development teams, authoring or approving Design Control deliverables such as Design FMEA, Quality Plans, and Design Verification and Validation Plans. Provide guidance and coaching for post market product sustaining activities, such as design changes Complaint handling and CAPA.
Provides guidance for: Market Specification, Technical Standards, Functional Specification, Design Verification, Design Validation, Test Method Validation, Failure Mode Effects Analyses, and Design Reviews (Possibly Lead)
Identifies the opportunities for continuous improvement of the Quality Systems, including the design control, document generation, and design testing processes.
Provides guidance and decisions on product development activities to ensure continued compliance with internal procedures, and applicable regulatory and international standards.
Apply Design for Reliability and Manufacturability tools and techniques to remediation projects as appropriate
Responsible for the assessment of component and system level specifications relative to customer needs and product performance specifications.
Prepare or direct the preparation of oral and written reports of gap analysis as required by the project or department management.
Prepare tradeoff studies and implementation alternatives to mitigate gaps.
Establish and optimize quality inspection methods, develop and evaluate test methods and product specifications.
Conduct complaint investigations, write reports and respond to customers
Document design review and risk assessment activities (FMEA) and ensure validations are conducted to the depth commensurate with identified risk.
Employ reliability methodology to statistical sampling plans, analyze adequacy of inspection criteria and techniques, recognize critical attributes when establishing validation requirements.
Experience with Design Control for IVD or Medical device industries.
Demonstrated change agent for Quality Systems
Ability to manage & implement multiple, large scale projects with minimal supervision, across the business &/or at remote &/or global locations.
ASQ, CRE or other certifications are a plus.
Required Qualifications :
Bachelor degree (or higher) in an Engineering Field
6 years in a quality engineering role with preference to a regulated industry (i.e., IVD, Medical Device, Automotive, etc.).
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.