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Quality Engineer II

Irvine, CA 92614

Posted: 07/10/2023 Employment Type: Contract Job Category: Engineering Job Number: 575398 Is job remote?: No Country: United States

Job Description


The Critical Care (CC) business unit is currently seeking a talented Quality Engineer in New Product Development role supporting the development of new and innovative hemodynamics monitoring platforms. This Quality Engineer (QE) will work in a fast-paced and dynamic environment where taking initiative and collaborating cross-functionally are critical for success.

Job Function:
  • Apply new product development knowledge and quality engineering principles to ensure compliance with regulatory requirements.
  • Focus on Design Control, Design Verification, Design Validation, Specification Development, and Test methods.
  • Develop, update, and maintain technical content of risk management files. Perform Failure Mode and Effects Analysis to identify product risks.
  • Apply statistical knowledge in developing Statistical Reliability tests and statistical sampling plans. Critical review and approval of design specifications and design changes; partner with R&D in the design of safe and effective Critical Care (CC) devices; partner with Manufacturing Engineering to develop critical manufacturing processes and provide technical quality engineering support for pilot production of CC devices Evaluate and review complex experiments and tests to create, validate, and improve products

Required Education & Skills
Bachelor's Degree in Engineering (Electrical preferred, Biomedical, or Mechanical) + minimum of 2 years of industry experience OR Master's Degree in Engineering + minimum of 1 years of industry experience Strong understanding of FDA medical device regulations. Design Control knowledge is a plus Must be able to work in a team environment, including inter-departmental teams. Ability to interact professionally with different functional groups including R&D, Regulatory, Operations, and Clinical Affairs. Experience working with R&D to affect design for manufacturing, mistake-proofing and robust design transfer to manufacturing Strong documentation, communication and interpersonal relationship skills including negotiating and relationship management skills

Knowledge of Electronics, IEC-60601 standard, and systems engineering is a plus.
  • Working knowledge and understanding of statistical techniques. Strong ability to identify, interpret, and apply statistical sampling methods. Ability to manage competing priorities in a fast paced environment Strong problem-solving, organizational, analytical and critical thinking skills
  • Ability to identify and describe quality system documentation components, including quality policies and procedures CQE (Certified Quality Engineer) or 6 sigma Black Belt certification are a plus
  • Demonstrate troubleshooting skills and capability in evaluating process changes and/or nonconformance for risk management or for developing technical justifications.
40-50 pay rate range
**salary will be commensurate with experience**

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

Take the next step in your career journey in the vibrant city of Irvine, California! Nestled in the heart of Orange County, this thriving community offers unparalleled growth opportunities and an unbeatable quality of life. With its close proximity to stunning beaches, world-class shopping at South Coast Plaza, a bustling culinary scene featuring diverse cuisine options, and cultural attractions like the Irvine Museum and Irvine Barclay Theatre, Irvine has something for everyone. Whether you're into outdoor activities in Irvine Regional Park or catching a game at the Angel Stadium of Anaheim or the Honda Center, this region has it all. Explore our job listings today and discover why Irvine is the perfect place to advance your career!

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.