Senior Design QA Engineer

Work Schedule

Environmental Conditions

Job 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 safer—while supporting your growth through meaningful career development and the opportunity to help solve some of the world’s 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.

The Senior DQA Engineer will lead all aspects of the ‘end to end’ design control and new product development lifecycle.

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.

• BS degree in Engineering or in a Science field such as Chemistry, Microbiology, Biology, or Biochemistry.

• 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.

• 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.

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.