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Thermo Fisher Scientific Staff Software Quality Assurance Engineer in San Diego, California

The Staff Software Quality Assurance Engineer will be responsible for supporting New Product Introduction (NPI) software programs by providing input to the development teams and authoring or approving Design Controls and Software Development Life Cycle deliverables. This SQA position is also responsible for providing guidance and coaching for post market product sustaining activities, such as software design changes and CAPAs.

Responsibilities

  • Provide guidance for software product development under Design Controls and Software Development Life Cycle processes: User and Product requirements, Functional Specifications, Configuration Management, Design Verification, Design Validation, Risk Management, Design Reviews, Pre- and Post-Market Software changes and Defect Tracking and Management.

  • Identify the opportunities for continuous improvement of the Quality Systems, including Software Development Life Cycle process and document generation.

  • Participate on team projects and assignments, facilitating or leading sub-teams as necessary.

  • Provide guidance and decisions on product development and software product development activities to ensure continued compliance with internal procedures, and applicable regulatory and international standards.

  • Assess software product regulations and standards impact to meet global requirements.

  • Work closely with New Product Introduction teams to meet software compliance requirements on schedule.

  • Ensure all necessary compliance documentation is current and available upon request.

  • Maintain awareness of applicable standards and regulations, and monitor activities related to change to the standards and regulation.

  • Monitor Software Design History File including formal assessments.

  • Assist in preparation and/or review documentation required for regulatory submissions.

  • Interface with corporate partners regarding quality issues, audits, and special projects.

  • Provide guidance to Manufacturing regarding quality and cGMP issues to ensure compliance with regulated standards.

  • Provides direction and guidance to other Design Compliance engineers as needed.

Minimum Qualifications and Requirements

  • Bachelor's degree in a Technical, Engineering, Life Sciences or Software discipline required.

  • Strong knowledge of Design Controls, Software Development Life Cycle, Risk Management, and regulatory guidelines and their application.

  • Experience in software product development.

  • Experience implementing Design for Compliance and training programs.

  • Experience in the Lab / IVD / Medical Device software field.

  • Excellent interpersonal and communication skills with ability to effectively interface with technical personnel at various levels of the organization.

  • Seven (or more) years of progressive professional experience in Software Design Compliance or Quality Engineering role.

  • Excellent written and verbal communication skills in English.

  • Ability to act quickly and decisively.

  • Ability to lead.

Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.

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