55 applicants

Company

Original Job Post

Katalyst HealthCares & Life Sciences · 2 days ago

Principal Quality Engineer

Billerica, MA

Contract

Onsite

Senior Level

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H1B Sponsorship

Comp. & Benefits

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Responsibilities

Develops, modifies, applies, and maintains quality standards and protocols for processing materials into partially finished or finished materials products.

Collaborates with engineering and manufacturing functions to ensure quality standards are in place.

Devices and implements methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment.

Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.

Ensures that corrective measures meet acceptable reliability standards, and that documentation is compliant with requirements.

May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control, and/or research and development as they apply to product or process quality.

Qualification

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Validation SkillsManufacturing Process ImprovementsUpdate pFMEAMedical DevicesCapital Equipment

Required

Validation skills (IQ, OQ, PQ, TMV, CSV, Equipment Validation)

Manufacturing Process Improvements

Update pFMEA

Preferred

Experience working with Disposable Medical Devices/capital equipment

Company

Katalyst HealthCares & Life Sciences

Katalyst Healthcares & Life Sciences offers data management, analysis, quality assurance, pharmacovigilance, and human resource services.

South Plainfield, New Jersey, USA

51-200 employees

http://katalysthls.com

H1B Sponsorship

Katalyst HealthCares & Life Sciences 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 (20)

2022 (46)

2021 (43)

2020 (53)