Insight Global · 1 week ago
Quality Engineer
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Responsibilities
Ensure effective quality strategies are created for validation of processes
Partner with cross-functional teams to ensure sound validation and smooth transitions to production go-live
Develop, write, review, maintain, and revise manufacturing documentation (i.e., process work instructions, manufacturing specifications, etc.)
Develop, write, and review various validation deliverables
Assess the need for risk mitigation techniques given product classification, potential defect types, defect frequency, severity, process controls, etc.
Investigate and understand current manufacturing operations, documentation, and execution systems for products in scope of project: documents investigations and implements changes required to manufacture products on new platforms
Ensure compliance with FDA, ISO, quality, safety, and environmental regulations
Qualification
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Required
A bachelor’s degree in engineering, Science, or related field
Minimum of 4 years of related experience
Must have process validation experience
Technical understanding of manufacturing equipment and processes
Foundry knowledge
CNC knowledge (Computer Numerical Control)
Knowledge of statistical software packages (Minitab, etc.)
Preferred
Technical training and experience using lean six sigma method
Ability to perform “hands on” troubleshooting and problem solving
Thorough understanding of GMP/ISO regulations and validation regulations
Demonstrated PM and project leadership abilities
Company
Insight Global
Insight Global provides top talent and staffing solutions that help job seekers find careers in healthcare, finance, IT, and government.
H1B Sponsorship
Insight Global 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 (66)
2022 (19)
2021 (5)
2020 (2)
Funding
Current Stage
Late StageTotal Funding
unknown2010-07-01Acquired· by Harvest Partners
Company data provided by crunchbase