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.
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
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
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 StageLeadership Team
Company data provided by crunchbase