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Thermo Fisher Scientific Sr Software Quality Assurance Engineer in Columbus, Ohio

Thermo Fisher Scientific Chromatography Data System Business Unit (eCDS) is looking for a key member to lead the global Quality function.

Chromeleon Chromatography Data System software is the laboratory workflow software that delivers superior compliance tools, networking capabilities, instrument control, automation, data processing, and much more. It is a full enterprise solution designed for tracking, accountability, and QA/QC that is incredibly easy to use and more 'right first time' results.

The Senior Engineer, Software Quality Assurance is a lead position responsible for implementing and improving eCDS Software Development Lifecycle. This role is integral for molding a culture of quality in best practices for software development, software product management and software support through establishment of processes and training.

This position reports directly to the Director of Quality and Regulatory of High-Performance Chromatography Solutions (HPCS).

Key Duties and Responsibilities

  • Ensure Software development design control, verification/validation is in compliance with applicable QMS and regulations

  • Represent Quality Assurance in sprint planning, reviews, retrospectives, release planning, demos and other Scrum-related activities

  • Develop and execute appropriate product quality/process improvement strategies with input from cross functional team based on risks and opportunities - e.g. continuously improve Software Development Life Cycle (SDLC) processes with the cross functional team

  • Work closely with Software development team, Software testing team and product owners to increase the reliability of the software via improving test automation infrastructure/test coverage and best practices to guarantee a quality user experience to our customers.

  • Support the qualification of software suppliers and service providers - verification/validation

  • Ability to support the Quality Management System - e.g. quality plans/initiatives, change control/management, CAPAs, Supplier management, training, and audit program

  • Ability to serve as a Quality resource/facilitator for audit programs including internal routine audits and external audits (e.g. ISO, Customer, etc.)

  • Collaborate with the various functions to assure effective implementation and adherence of Quality Assurance initiatives and process improvement

  • Implement and training Quality processes for eCDS teams

  • Support quality metrics and reporting for monthly and quarterly business reviews

  • Ensure continuous improvement through the Practical Process Improvement (PPI)

  • Instill and maintain a quality culture

Minimum Requirements/Qualifications:

  • Bachelor of Science Degree in Computer Science, Computer Engineering or related engineering degree preferred

  • 5+ years of relevant software quality assurance experience in a Medical device, Pharmaceutical, Life Sciences or related industry

  • Solid working experience/proficiency with common software project management tools - e.g. JIRA, Github, etc.

  • Fundamental working knowledge and experience with ISO 9001

  • Experience in/working knowledge of ISO 13485, ISO 62304, 21CFR820, GAMP5 and GxP requirements preferred

  • Ability to travel domestically and internationally - up to 10%

  • Expert knowledge and experience in the following areas:

  • Various Software Development Life Cycle (SDLC) processes - e.g. Agile, Waterfall

  • Configuration management and change management processes

  • CAPA (Corrective and Preventive Actions) process

  • NPDI (New Product Development Introduction) process with a focus on quality related activities

  • Verification and Validation

  • Successful process improvement planning and implementation

Desired Qualifications:

  • Contributes as a valued team member and colleague

  • Experience working and providing customer support, investigations, and relationship management

  • Demonstrates personal awareness and desire for continual learning and personal development

  • Hands-on and action oriented - Normally receives little instruction on day-to-day work, general instructions on new assignments

  • Must possess the presentation skills and professionalism to project a professional image, both internally and externally

  • Strong interpersonal, verbal and written communications skills are essential

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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