Engineer II, QA @ Thermo Fisher Scientific | Jobright.ai
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Thermo Fisher Scientific · 3 days ago

Engineer II, QA

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BioinformaticsBiotechnology
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H1B Sponsorship
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Responsibilities

Responsible for Quality-related activities at the Greencastle, PA
Improve all aspects of the QMS from planning to implementation on topics such as Distribution Quality Assurance, auditing, document management, CAPA resolution
Drive continuous improvement across the Distribution Quality function, including a focus on reducing customer complaints.
Develop and implement quality control procedures and standards
Collaborate with diverse teams to ensure flawless execution of quality assurance processes
Conduct thorough audits and inspections to identify areas for improvement
Proactively identify and resolve quality issues, ensuring compliance with regulations and standards
Participate in Customer/Internal audits
Responsible for the Trackwise system – non-conformances, deviations, CAPA
Provide Quality guidance to product-related investigations, deviations, change controls, validation protocols, validation reports, and SOPs
Lead the Change Control System and perform Risk Assessments
Provide training and support to other departments within Distribution
Work in a warehouse environment under various temperatures including room temperature, cold-room, and freezer-room.
May be required to routinely push and pull and/or lift up to 40 lbs (20 kg).
Perform other related duties as assigned

Qualification

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Quality AssuranceRegulatory Guidelines ISO13495Regulatory Guidelines ISO9001Distribution PracticesQuality InvestigationsRoot Cause AnalysisQuality ToolsProblem-SolvingAnalyticalAttention to DetailCommunicationCollaborationInfluencingResults-OrientedSelf-MotivatedTeamwork

Required

Bachelor's degree or equivalent experience in Engineering or a related field
Minimum of 3 years of proven experience in Quality assurance
Knowledge of regulatory guidelines: ISO13495, ISO9001
Understanding of Distribution practices
Proven record of conducting Quality investigations including root cause analysis using Quality tools
Strong analytical skills and attention to detail
Excellent communication and collaboration skills
Successful with influencing and getting results
Self-motivated with the ability to work as part of a team and/or independently

Company

Thermo Fisher Scientific

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

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)

Funding

Current Stage
Public Company
Total Funding
$11.05B
Key Investors
National Grid
2023-08-07Post Ipo Debt· $2.95B
2023-03-27Grant· $0.5M
2022-11-15Post Ipo Debt· $1.29B

Leadership Team

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Daniella Cramp
Senior Vice President and President
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Frederick Lowery
Senior Vice President Thermo Fisher and President Customer Channels
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Company data provided by crunchbase
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