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Quality Engineer I

Irvine, CA 92618

Posted: 04/08/2024 Employment Type: Contract Job Category: Engineering Job Number: 603607 Is job remote?: No Country: United States

Job Description

Pay is commiserate with experience and ranges between $35-40/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.

Minimum Requirements:
  • Bachelors degree in Engineering 1- 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
  • Bachelors degree in Engineering

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Irvine, CA

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Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.