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Design Compliance Engineer - Remote

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Posted 2 months ago United States Salary undisclosed
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Job Description

Job Title: Design Quality Assurance Engineer

Requisition ID: 182699BR

As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Location/Division Specific Information

Remote / Genetic Sciences Division

How will you make an impact?

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

What will you do?

  • Provide guidance for product development under Design Controls: User and Product requirements, Functional Specifications, Design Verification, Design Validation, Test Method Validation, Risk Management, and Design Reviews.
  • Identify the opportunities for continuous improvement of the Quality Systems, including Design Controls, document generation, and design testing processes.
  • 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 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 procedures, 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

  • 7-10 years of experience in a Quality Engineering role, with emphasis on ISO 13485 requirements, ISO 14971 requirements, knowledge of GMP
  • 7+ years of progressive professional experience in Design Compliance or Quality Engineering role.
  • Experience in instrumentation and software product development.
  • Experience implementing Design for Compliance and training programs.
  • Experience in the Lab / IVD / Medical Device field is preferred.​

Knowledge, Skills, Abilities

  • Strong knowledge of Design Controls, Risk Management, and regulatory guidelines and their application.
  • Excellent interpersonal and communication skills with ability to effectively interface with technical personnel at various levels of the organization.
  • Excellent written and verbal communication skills in English.
  • Ability to act quickly and decisively.
  • Ability to lead.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one global team of 90,000 colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

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.

Accessibility/Disability Access

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

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