Design Assurance Engineer - Medical Devices jobs in United States
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Planet Pharma · 9 hours ago

Design Assurance Engineer - Medical Devices

Planet Pharma is an established Medical Device company seeking an experienced Design Quality Engineer for its growing team. The role involves leading quality improvement projects, ensuring regulatory compliance, and collaborating with engineering and manufacturing functions to maintain quality standards.

BiotechnologyHealth CarePharmaceutical
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H1B Sponsor Likelynote
Hiring Manager
Brad Phelps
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Responsibilities

Be the quality lead representative on global quality improvement, cost-down, and efficiency projects
Engage in, review, and approve qualification deliverables, protocols, and processes; ensure products and quality processes maintain regulatory compliance while achieving cost down and efficiency targets
Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product
Collaborates with engineering and manufacturing functions to ensure quality standards are in place
Devises 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

Design AssuranceQuality EngineeringLean/Six SigmaCross-functional collaborationBachelor's Degree

Required

Bachelor's Degree within an Engineering realm
5-7+ years of experience within Design Quality Engineering

Preferred

General quality experience in med device preferred
Design Assurance/Design Quality; self-driven, independent ability to engage with cross functional teams and manage project workload
Lean/six sigma project improvement experience

Company

Planet Pharma

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Planet Pharma is a pharmaceuticals company.

H1B Sponsorship

Planet Pharma 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
Represents job field similar to this job
Trends of Total Sponsorships
2022 (3)
2021 (5)
2020 (5)

Funding

Current Stage
Late Stage

Leadership Team

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Cynthia Lewis
Senior Executive Recruiter, Life Sciences - PPG Advisory Partners
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Emma Morris
President, PPG Advisory Partners
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Company data provided by crunchbase