Senior Design QA Engineer
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Job Location:
Monthly Salary:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
At Thermo you will shape work with a global impact! Every day we live our Mission to enable our customers to make the world healthier cleaner and saferwhile supporting your growth through meaningful career development and the opportunity to help solve some of the worlds toughest scientific challenges.
Within our Genetic Sciences Division (GSD) we deliver industry-leading genomic technologies that advance scientific discovery empower applied markets and improve global health outcomes.
Discover Impactful Work:
The Senior DQA Engineer will lead all aspects of the end to end design control and new product development lifecycle.
A day in the Life:
The Senior Design Quality Assurance Engineer will:
- Lead Design Controls activities provide guidance to Product Development Teams on Design inputs and outputs V&V Risk Management Design Reviews Design Changes and Design Transfer.
- Conduct/lead/support Risk analysis activities and implementation of risk controls to ensure that products are safe and effective.
- Lead and support product development teams through processes to ensure design robustness processes include: reliability statistics software and human factors.
- Ensure product development activities are conducted in compliance with all applicable regulatory requirements international standards and internal procedures.
- Collaborate across functions and provide oversight for the satisfactory resolution of quality and compliance issues.
- Ensure that the product Design History File is auditable traceable and complete. Serve as the Authority on the DHF for external regulatory inspections and audits.
Education
- BS degree in Engineering or in a Science field such as Chemistry Microbiology Biology or Biochemistry.
Experience
- 5 years of Quality or equivalent experience or a combination of work experience and education in a Quality/Quality related field (QE QA QC Supplier Quality)
- 1 years of experience in New Product Introduction 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 management product and process V&V methodologies Design Transfer and manufacturing/ production process control methodologies.
- Experience with applicable FDA European and other relevant clinical/regulatory requirements and international standards including ISO 9001 ISO 13485 ISO 14971 EU IVDR/MDR 21CFR 820 Quality System Regulation etc. desired.
- ASQ certifications (CQA CQE CRE Six Sigma etc.) desired.
Knowledge Skills Abilities
- Strong verbal and written communication skills at multiple levels in the organization.
- Ability to work optimally within a team in a fast-paced changing environment.
- Strong impact and influence including the ability to provide feedback to build positive relationships and improve business results.
- Ability to travel.
Benefits
We offer a competitive total compensation package designed to attract top talent. Thermo Fisher Scientific offers employment with an innovative forward-thinking organization and outstanding career and development prospects. We offer an exciting company culture that stands for integrity intensity involvement and innovation.
Required Experience:
Senior IC
Key Skills
- Electrical Engineering
- SOC
- PCB
- Warehouse Management
- Warehouse Experience
- CAD
- Creo
- SolidWorks
- Data Mining
- Digital design
- Mechanical Engineering
- Autocad
About Company
Electron microscopes reveal hidden wonders that are smaller than the human eye can see. They fire electrons and create images, magnifying micrometer and nanometer structures by up to ten million times, providing a spectacular level of detail, even allowing researchers to view single a ... View more
