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Company

Original Job Post

Thermo Fisher Scientific · 3 days ago

Engineer III, QA

Frederick, MD

Full-time

Onsite

Mid Level

2+ years exp

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BioinformaticsBiotechnology

H1B Sponsorship

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Insider Connection @Thermo Fisher Scientific

Discover valuable connections within the company who might provide insights and potential referrals, giving your job application an inside edge.

Responsibilities

Working with multi-functional departments for investigations, corrections/corrective actions to ensure accurate documentation and closure, provide trending and issues as appropriate.

Analyze and trend all types of data (CAPA, problem records, complaints, on market surveillance) to identify deficient areas and initiate quality improvement projects.

Participate in third party audits, external customers, and Agency inspections as needed and support internal activities concerning any identified nonconformities.

Write, review, and approve CAPAs to ensure timely resolution of quality problems.

Promote and implement improvements and compliance with site Quality Management System requirements.

Prepare clearly written business communications.

Write, review, analyze and revise written relevant Stand Operating Procedures (SOPs) and submit procedural changes as needed to meet site, regulatory requirements.

Support the quality department as assigned.

Qualification

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ISO 13485GMPQuality AssuranceQuality SystemsQuality EngineerDigital literacyAgileTrackwiseE1Quality toolsMethodologiesRoot cause analysisRegulatory requirementsBusiness requirementsWork prioritizationProblem-solvingOrganizationalPositive demeanor

Required

Bachelor's degree in life sciences, engineering, process engineering, chemistry, biotechnology or related sciences required.

Experience working in ISO 13485 and/or GMP environment

2+ years of work experience in Quality Assurance/Systems/Engineer role

Strong digital literacy (Office, Project, Teams, Visio, Word, Excel); experience with Agile, Trackwise and E1 a plus.

Experience with Quality tools, methodologies and investigations, including root cause analysis.

Strong analytical and problem-solving skills with attention to detail. Can find creative solutions that meet regulatory and business requirements.

Proven organizational skills and can balance sophisticated and routine work activities with competing priorities.

Highly upbeat, positive demeanor, works well under stress

Benefits

Healthcare

Annual Incentive Plan Bonus

Range of Employee Benefits

Company

Thermo Fisher Scientific

Glassdoor

3.6

Thermo Fisher Scientific is a biotechnology and laboratory equipment company that provides a wide range of scientific products and services.

Founded in 1956

Waltham, Massachusetts, USA

10,001+ employees

http://www.thermofisher.com

H1B Sponsorship

Thermo Fisher Scientific has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Trends of Total Sponsorships

2023 (173)

2022 (314)

2021 (349)

2020 (251)