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Company Name:
Thermo Fisher Scientific
Approximate Salary:
Not Specified
Santa Clara, California
United States
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Experience level:
Education level:

Sr. Quality Specialist

Job Description

Job Title: Sr. Quality Specialist
Requisition ID: 78733BR

When you join us at Thermo Fisher Scientific, you ll be part of a smart, driven team that shares your passion for exploration and discovery. With revenues of $22 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

Job Description and Key Responsibilities

When you re part of the team at Thermo Fisher Scientific, you ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you ll be supported in achieving your career goals.
Reporting to the Director of Global Quality and Compliance, you will be responsible for supporting software development and validation activities for New Product Introduction (NPI ) and QMS software compliance by providing input to the development teams, authoring or approving software-related deliverables such as Risk Management Files, Quality Plans, and Software Design Verification and Validation Plans and Reports.

  • Provides software development and validation guidance/support on NPI projects in regards to User Requirements and Specification, Design Requirements and Specification, Design Verification, Design Validation, Test Method Validation, Risk Management, Design Transfer, Design Reviews and Product Lifecycle Management.
  • Provides Quality Management System (QMS) software development and validation guidance/support.
  • Provides Regulatory and International Standards guidance/support.
  • Facilitates software risk management activities using Risk Assessment Process, as applicable.
  • Reviews and approves product software specification documentation for new products and for QMS systems.
  • Defines work breakdown structures and quality plans for software development, as required.
  • Ensures design changes are captured and follow the design change control process.
  • Identifies the opportunities for continuous improvement of the Quality Systems, including the design control, risk management, document generation, and design testing processes.
  • Participates on team projects and assignments, facilitating or leading teams as necessary.
  • Use of risk management tools to evaluate impact of change.
  • Ensure software verification and validation requirements are reviewed and defined appropriately
Minimum Qualifications
  • Position requires a Bachelor s of Science Degree in Engineering or equivalent experience, and a minimum of 5 years direct Quality Engineering experience with expertise in software Design Control for medical device industries.
  • Experience in regulated medical device manufacture with compliance to FDA Quality System Regulation, EU Medical Device Directive and ISO 13485, as well as IEC62304 is required
  • Working knowledge of EN ISO 14971, especially Software Hazard Analysis
  • Working knowledge of Excel, Word, Access, quality software, and statistical methods (SPC, DOE, Gauge R&R, etc.)
  • Working knowledge of Electronic records/signature compliance (21 CFR Part 11).
  • Working knowledge of software requirement specifications, software test methods, for the design, verification, and validation of medical device products.

Preferred Qualifications (Nice to Have)
  • Project planning and advanced computer skills a plus.
  • Experience in New Product Development from product realization to product launch as a technical function is a plus.
  • ASQ certification or Lean Six Sigma certification is a plus.

Professional Characteristics:
  • Work attitude that exhibits drive, creativity, collaboration, assertiveness, good judgment, decision making and ambition.
  • Excellent interpersonal skills: ability to build and maintain relationships with internal and external customers; highly functioning team leader and team member in a multi-skilled, dynamic business environment.
  • Leadership Skills: Proven ability to influence others and lead significant change.
  • Strong communication skills both written and verbal

This position is not approved for relocation assistance

At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission enabling our customers to make the world healthier, cleaner and safer. Apply today

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here for further assistance.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Associated topics: .net, application developer, architecture, back end, c#, design, java, matlab, programming, software architect

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