Sr Design QA Engineer

Work Schedule

Environmental Conditions

Job Description

Join Thermo Fisher Scientific to contribute globally, enabling customers to advance science and solve challenges like environmental protection and cancer research.

Thermo Fisher Scientific's Genetic Sciences Division provides top genetic sciences tools for scientific progress and global health enhancement.

Lead 'end to end' design control and new product development, ensuring flawless market launch.

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.

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

• 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.