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Quality Engineer

Alameda, CA 94501

Employment Type: Contract Category: Quality Engineer Job Number: 10034 Pay Rate: $55/hr. - $60/hr.

Job Description

  • BS in Engineering and 2+ years’ experience working in product design and development 
  • Strong knowledge of quality engineering for medical devices and IVDs 
  • Familiar with FDA and EU regulations 
  • Understanding of the Quality Management System life cycle 
  • Hands on approach with excellent communication skills 
  • Equipment and vendor qualifications 
  • Coordinate the execution and documentation of Design Validation and Verification activities. 
  • Manage and keep up to date Design History Files and Medical Device Files for products. 
  • Familiar with Risk Based Approach to processes. 
  • Demonstrate good working knowledge and application of validation and statistical techniques to comply with associated regulatory requirements and internal standards 
  • ISO 13485, ISO 14971, 21 CFR part 820, IEC 61010, IEC 60601 and Quality System Regulations understanding with a focus on Design Controls and Risk Analysis 
  • Hands on experience with nucleic acid amplification techniques, immunoassay tests, and lateral flow assays 

Primary Responsibilities 
  • Support a team of engineers to ensure the development of quality processes and products 
  • Able to work on large and small projects across the engineering team 
  • Manage and document internal processes and protocols and generate accurate reports for all tests 
  • Utilize engineering knowledge to provide solutions to challenging problems 
  • Communicates with suppliers on a technical basis to ensure a quality product 
  • Create solutions for internal and external tests to determine the quality of the product and supporting equipment 
  • Able to quickly learn new software and output meaningful results 
  • Comfortable working with some ambiguity on early-stage development 
  • Hands on self-starter with strong time management skills 
  • Communicates effectively with cross functional teams and within group 
  • Ensure quality on consumables with sample preparation and microfluidics for IVD applications 
  • Manage multiple tasks and prioritize effectively with limited oversight 
  • Use and improve test stands and fixtures 
  • Must be self-motivated and able to work in a fast-paced environment 

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