Quality Assurance Engineer

13 Nov 2024

Vacancy expired!

Hello, OneAPPS (www.oneapps.com) is a Technology consulting firm based out of New York and offices across US. We are working on various projects involving diverse, multicultural teams with clients across the US. We are an invaluable partner and our teams have collaborated to support the growth of our clients. With more than 7 locations worldwide we help our clients to deliver their projects smoothly. We look forward to getting to know you and working with you.

Quality Assurance Engineer

Carlsbad CA,

Fully Onsite from Day 1
  • Represent the Quality function to provide design assurance support in the design and development of medical device products and facilitate the application of design controls and risk management.
  • Providing training and guidance to other Design Quality Engineers and Quality Assurance professionals on new product development and change processes.
  • Act as a reviewer and approver of validation methods and protocols, test methods, statistical analysis methods and specification development.
  • Review new and modified product designs for quality. Ensure that product development projects and changes to existing products are conducted in compliance with the FDA Quality System Regulation and other global regulations.
  • Act as a key contributor to development and validation plans and processes.
  • Act as a key team member in establishing, communicating and mitigating risks.
  • Ensure successful transfer of new products to manufacturing.
  • Review design history files and technical files for conformance to applicable requirements.
  • Support the continuous improvement to the Quality Management System, with a specialty focus on design controls and associated processes with software and hardware development.
  • Identify and propose remediation for existing and potential quality issues; act as project team quality solution provider to maintain compliance.
  • Provides leadership in all areas of the Quality System, including but not limited to design controls, risk management, etc.
  • Provides leadership in the understanding of FDA and applicable non-US regulations pertaining to medical or pharmaceutical manufacturing, including hardware, software, and bioassay systems.
If this role sounds like you, we invite you to apply. Thanks.

  • ID: #22687605
  • State: California Carlsbad 92008 Carlsbad USA
  • City: Carlsbad
  • Salary: Depends on Experience
  • Job type: Permanent
  • Showed: 2021-11-13
  • Deadline: 2022-01-09
  • Category: Software/QA/DBA/etc