Planet Pharma ยท 1 day ago
Quality Engineer
Irvine, CA
Full-time
Onsite
Mid, Senior Level
$50/hr - $55/hr
3+ years expPlanet Pharma is a leading Medical Device company seeking a Quality Engineer to research and test products, equipment, systems, and processes. The role involves collaborating with R&D and Operations teams, optimizing manufacturing processes, and ensuring compliance with quality standards.
BiotechnologyHealth CarePharmaceutical
Hiring Manager
Antoinette (Annie) DiSano
Responsibilities
Collaborate with the R&D and Operations teams in the areas of Design Engineering, Risk Management, Design Controls, Design Verification, Statistical Techniques, Test Method Development, Process Development, Quality Assurance, and Regulatory Compliance
Investigate moderately complex manufacturing product quality for all production processes based on engineering principles, analyze results, and make recommendations
Identify and ensure the optimization of complex Manufacturing and/or R&D processes using engineering methods for design for manufacturing and for continuous process improvement. Identify opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk
Lead Risk Management process for project in compliance to appropriate external standards and corporate policies, to ensure critical to quality features are identified and addressed appropriately
Responsible for creating and maintaining risk management documentation such as risk management worksheet, FMEAs in alignment with ISO:14971
Provide integral technical input for the development of project plans, project timelines and strategy to support premarket approval of products
Partner with R&D engineers to support design verification/validation strategy and testing, including test method development/validation activities
Strong leadership and collaboration with other leaders in project and across the organization
Mentor engineers in understanding of quality systems and strategies within new product development
Support root cause investigations/product evaluations for product failures encountered during clinical use using engineering methods (Six Sigma, DMAIC, etc.)
Support resolution of manufacturing and compliance issues (i.e. CAPA, non-conformances, audit observations, etc.) utilizing problem solving tools
Qualification
Required
Bachelor's degree in engineering required
3-7 years of experience
Medical Device manufacturing experience required
New product development experience
Company
Planet Pharma
Planet Pharma is a pharmaceuticals company.
1001-5000 employees
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
Cynthia Lewis
Senior Executive Recruiter, Life Sciences - PPG Advisory Partners
Emma Morris
President, PPG Advisory Partners
Company data provided by crunchbase