About Thermo Fisher Scientific
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.
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. This position will also be responsible for providing 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.
- Identifies the opportunities for continuous improvement of the Quality Systems, including the design control, document generation, and design testing processes.
- Participates on team projects and assignments, facilitating or leading teams as necessary.
- Provides guidance to test methods, equipment acquisition, sample plan definition, and validation development.
- Provides guidance and decisions on product development activities to ensure continued compliance with internal procedures, and applicable regulatory and international standards..
- Provides direction and guidance to other Quality engineers as needed
- 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.
- Provide effective support for multiple projects, balancing priorities and resources appropriately to meet both project and management expectations.
- 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.
- Collect, analyze and present quality data.
- Establish and optimize quality inspection methods, develop and evaluate test methods and product specifications.
- Write and conduct validations (IQ/OQ/PQ) for manufacturing processes and equipment.
- 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.
- Develop and write protocols for new procedures and existing procedures.
- Demonstrated experience on Design Control for IVD or Medical device industries.
- Demonstrated change agent for Quality Systems - that includes ability to challenge the status quo & effecting change to achieve business results.
- Demonstrated ability to manage & implement multiple, large scale projects with minimal supervision, across the business &/or at remote &/or global locations.
- Requires the ability to perform independently & as part of a team.
- Must be able to influence & negotiate with people & resolve issues.
- Ability to make rational, objective & appropriate decisions relating to company & department needs & resource allocation.
- Ability to identify customer needs & issues & develop realistic solutions to meet needs & solve problems.
- Ability to communicate recommendation and decisions across a wide spectrum of the organization.
- 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.).
- Excellent communication and presentation skills
- ASQ, CRE or other certifications are a plus.