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Hybrid Sr Design QA Engineer bei Thermo Fisher Scientific

Thermo Fisher Scientific · Singapore, Singapur · Hybrid

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Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job 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 Scientific's 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.
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