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Engr II

Irvine, CA 92614

Posted: 04/01/2024 Employment Type: Contract Job Category: Engineering Job Number: 604036 Is job remote?: No Country: United States

Job Description


Target PR Range: 40-50/hr
*Depending on experience

Job Description:

Perform Post Market customer complaints investigations, providing detailed analysis of the process and the data; determine root causes of the nonconformities in order to establish corrective and preventive actions. Execute complaint investigations multifunctional approach and issues addressed in a systematic, methodical manner. Oversight of all complaints that require investigation through the different phases. Ensure on time completion of complaints. Work closely with complaint investigation owners to resolve issues and ensure those that have passed their due dates are addressed. Ensure complaint investigations are adequate and comply with applicable procedures.

Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and systems/procedures to optimize product development, internal and external device manufacturing, and device distribution. Please refer to the job description for additional details.

Key Responsibilities:
  • Investigate moderately complex product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports.
  • Develop, update, and maintain technical content of risk management files
  • Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes
  • Assign support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinate technician work.
  • Other incidental duties assigned by Leadership

Additional Skills:
  • Proficient at MS Suite, especially Excel and Power Point
  • Experience with Power BI
  • Understanding of data trending and analytics, data pulls/refresh data sources
  • Post market surveillance experience

  • General background/understanding of Post Market Analysis:
    Complaints FCA PRA CAPA

  • Understanding of regulations, a plus; EUMDR, FDA, ISO standards
  • Medical device experience
  • Excellent writing skills
  • Ignite preferred
  • ETQ (Reliance) experience preferred

Education and Experience: Bachelor's Degree in in Engineering or Scientific field including either industry or industry/education, minimum of 2 years' experience Required

Or

Master's Degree or equivalent in in Engineering or Scientific field including either industry or industry/education Required or internship, senior projects, or thesis Required

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 is an equal opportunity employer. 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.