Development Quality Engineer

• Location: Pomona, California
• Type: VMS
• Job #38678

We are seeking a Design Quality Engineer to join a global medical device and diagnostics company in Pomona, CA. They create breakthrough products – in diagnostics, medical devices, nutrition and branded generic pharmaceuticals – that help you, your family and your community lead healthier lives, full of unlimited possibilities.

This role will be responsible for design quality engineering activities that span the product development process and design transfer to manufacturing. Included in the role is the responsibility to develop risk management documentation, and use risk management to address product design and process changes, product and process quality issues, and compliance issues.

Pay rate: $46.67 – 48.28/hr
Status: Contract
Responsibilities:

• Act as quality assurance support for the design and development of In-Vitro Diagnostics (IVD) medical device products, facilitating the application of design/change controls, risk management, quality plan and implementation of design and development plan.
• Work closely with R&D, Manufacturing, Quality Control, and Applications Support management to prevent non-conformities and provide solutions to complex issues
• Support the change control process by reviewing proposed changes, performing risk assessments, and assessing the adequacy of verifications and validations.
• Perform failure mode analysis on new or existing products. Ensure all reasonable failure modes are identified.
• Coordinates for both new products/processes and changes to existing products/processes develop verification and validation plans that assess if requirements are met.
• Demonstrates commitment to the development, implementation and effectiveness of Quality Management System per ISO, FDA, and other regulatory agencies.

Requirements:

• BS/BA degree in Engineering or field of science
• Minimum of 2-5 years’ experience in a quality role within a highly regulated industry
• Minimum of 2 years hands-on risk management experience in developing and maintaining risk management files such as UMFMEA/DFMEA/PFMEA, Plans, Reports, etc.
• Minimum of 2 years of quality engineering experience (design controls/change control, process validation, on market engineering support and risk management) in a regulated environment.
• Experience reviewing and approving plans and reports for design verification, design validation, and process validations required.