97 applicantsPosted by Agency
Proclinical Staffing ยท 2 days ago
Quality Engineer
Alameda, CA
Full-time
Onsite
Entry, Mid Level
$50/hr - $55/hr
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Hiring Manager
Anderson Maldonado
Insider Connection @Proclinical Staffing
Responsibilities
Collaborate with a team of engineers to ensure high-quality processes and products.
Manage projects across the engineering team.
Document internal processes and protocols, and generate accurate reports for all tests.
Provide solutions to challenging problems using engineering knowledge.
Communicate with suppliers to ensure product quality.
Develop solutions for tests to determine product quality and supporting equipment.
Learn new software quickly and produce meaningful results.
Manage multiple tasks and prioritize effectively with limited oversight.
Improve test stands and fixtures.
Qualification
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Required
Bachelor's degree in engineering or another related field.
Experience in product design and development.
Proven working experience with manufacturing and design transfer.
Hands-on experience with nucleic acid amplification techniques, immunoassay tests and lateral flow assays.
Strong knowledge of quality engineering for medical devices and IVDs.
Familiarity with FDA and EU regulations.
Understanding of the Quality Management System life cycle.
Excellent communication skills.
Ability to coordinate the execution and documentation of Design Validation and Verification activities.
Familiarity with Risk Based Approach to processes.
Good working knowledge and application of validation and statistical techniques.
Understanding of ISO 13485, ISO 14971, 21 CFR part 820, IEC 61010, IEC 60601 and Quality System Regulations with a focus on Design Controls and Risk Analysis.
Preferred
Experience with manufacturing and design transfer is preferred.
Company
Proclinical Staffing
At Proclinical Staffing, our life science recruitment services support our partners with permanent and contract vacancies by connecting them with specialist talent across the globe.
Founded in 2005
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase
