Sr Design QA Engineer
Sr Design QA Engineer
Posted on :
21-08-2025
Employer Active
1 Vacancy
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Job Description
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
Join Thermo Fisher Scientific to contribute globally enabling customers to advance science and solve challenges like environmental protection and cancer research.
Location/Division Specific Information
Thermo Fisher Scientifics Genetic Sciences Division provides top genetic sciences tools for scientific progress and global health enhancement.
Discover Impactful Work:
Lead end to end design control and new product development ensuring flawless market launch.
A day in the Life:
The Senior Design Quality Assurance Engineer will:
- Lead and support Design Controls activities provide mentorship to Project Core Teams on User and Product requirements Functional Specifications Design Verification and Validation Risk Management Design Reviews Pre-market Design Changes and Design Transfer.
- Conduct and support risk analysis estimation evaluation planning and implementation of risk controls for product and process identified risks to ensure that products are safe and effective.
- Lead and support product development teams through processes to ensure design robustness including reliability statistics software and human factors.
- Ensure product development activities align with all applicable regulatory requirements international standards and internal procedures.
- Collaborate with cross-functional team members and provide oversight for the satisfactory resolution of quality and compliance issues.
- Support design transfer activities for new product introduction projects.
- Ensure the product Design History File is auditable traceable and complete. Serve as the Authority on the Product Design History File for external regulatory inspections and audits.
Education
- BS degree in Engineering or in a Science field such as Chemistry Microbiology Biology or Biochemistry or equivalent experience.
Experience
- 5 years of Quality Assurance or equivalent experience or a combination of work experience and education in a Quality or Quality-related field (Quality Engineering Quality Assurance Quality Control Supplier Quality).
- 1 years of experience in New Product Development activities.
- 1 years of working in the Medical Device In-Vitro Diagnostics or other regulated industry.
- Solid understanding of product development lifecycles design change and change control risk activities and risk management product and process verification and validation methodologies Design Transfer and manufacturing/production process control methodologies.
- Desired: Experience in FDA European and other clinical/regulatory requirements including ISO standards.
- ASQ certifications (CQA CQE CRE Six Sigma etc.) desired.
Knowledge Skills Abilities
- Strong verbal and written communication skills and can effectively communicate at multiple levels in the organization.
- Ability to work effectively within a team in a fast-paced changing environment.
- Strong leadership skills including the ability to provide positive and constructive feedback to build positive relationships and improve business results.
- Ability to travel.
Required Experience:
Senior IC
Employment Type
Full-Time
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