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Quality Design Compliance Staff Engineer

Employer
Thermo Fisher Scientific
Location
Frederick County, MD
Closing date
Sep 17, 2021

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Sector
Science, Physical Sciences and Engineering
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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.

Location/Division Specific Information
Frederick, MD.
Clinical Sequencing Division

How will you make an impact?

Work with quality team to ensure company goals and objectives, policies and procedures are in compliance with Quality Systems, cGDP and FDA regulations

What will you do?
  • Provides guidance for product development under Design Control: Market/User requirements, Functional Specification, Design Verification, Design Validation, Test Method Validation, Risk Management, and Design Reviews.
  • Identifies the opportunities for continuous improvement of the Quality Systems, including the design control, document generation, and design testing processes.
  • Participates on team projects and assignments, facilitating or leading sub teams as necessary.
  • Provides guidance and decisions on product development activities to ensure continued compliance with internal procedures, and applicable regulatory and international standards.
  • Assess product regulations and standards impact to meet global requirements
  • Work closely with new product introduction teams to meet 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.
  • Assist in preparation and/or review documentation required for regulatory submissions.
  • Provide leadership to sites to ensure global product compliance requirements are understood.
  • Advise Divisional and Business Unit leadership teams regarding strategies related to new and changing regulations and standards, including assessment of business compliance risk
  • Oversee the operations of the design compliance group to ensure accurate results, adherence to Company protocols, and timely completion of projects.
  • 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


How will you get here?
Education
  • Bachelor's degree in a Technical or Engineering discipline required.
Experience
  • Five (or more) years of progressive professional experience in Design Compliance or quality engineering role
  • Experience implementing Design for Compliance and training programs.
  • Experience with Lab/ IVD/ Medical device is preferred.
  • Experience in instrumentation and software product development is a plus

Knowledge, Skills, Abilities
  • Strong knowledge of Design Control, Risk Management as well as regulatory guidelines and their application.
  • Excellent written and verbal communication skills
  • Ability to act quickly and decisively.
  • Ability to lead


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! http://jobs.thermofisher.com

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.
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