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Quality Engineer I

Yoh, A Day & Zimmermann Company
Irvine, CA
  • Expired: over a month ago. Applications are no longer accepted.
Job Description
We have a contract opportunity for a Quality Engineer in Irvine California. This position is approved for 1 year wit the possibility of being extended an additional year.

Pay Rate: $33.50/Hr.

The Quality Engineer is responsible for maintaining quality and control of manufacturing processes and post-market performance of medical devices. Responsibilities include collaborating with internal and external stakeholders to achieve company objectives, leading technical root cause investigations, developing, and executing risk-based decisions, resolving and documenting customer complaint and manufacturing investigations, and representing Quality in cross-functional projects.

Job Duties:
  • Develops and executes plans for quality and control to ensure manufacturing continuity and product conformance.
  • Leads investigations into production and customer-facing quality issues to identify root cause, implement corrective and preventative actions, and monitor effectiveness
  • Monitors and analyses product performance of medical devices using a statistical and risk-based approach. Considers any quality, compliance, customer, and business risks.
  • Performs hands-on troubleshooting of customer returned devices and manufacturing nonconformities and completes associated technical documentation
  • Develops tools to communicate complex technical problems and solutions to a variety of audiences within the organization
  • Proficient in project management, data analysis, root cause analysis, communication, and risk determination
  • Ensure compliance with the company's Quality System policies and procedures and applicable external requirements and standards, including FDA, ISO 13485, and other worldwide regulatory agencies as pertaining to medical devices.

Requirements:
Bachelor’s degree in Engineering
2 years of relevant experience in a regulated industry (FDA environment preferred)
Knowledgeable of FDA regulations, 21 CFR part 820 and Part 803 and ISO 13485 standard

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.

Yoh, A Day & Zimmermann Company

Address

Irvine, CA
USA

Industry

Manufacturing