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Quality Engineer II

Irvine, CA 92614

Posted: 01/14/2025 Employment Type: Contract Job Category: Engineering Job Number: 617043 Is job remote?: No Country: United States

Job Description

Target PR Range: 34-44/hr
*Depending on experience
Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated. Groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. Its our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

This Quality Engineer II will apply knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and systems/procedures to optimize product design, internal and external device manufacturing, and device distribution. Furthermore, this Quality Engineer will coordinate and perform complaint investigations as well as DMR/DHR changes in support of clinical inventory.

How you will make an impact:
  • Support areas of Quality Assurance, Design Controls, Risk Management, Manufacturing Controls, and Statistical Techniques for New Product Development (NPD) programs
  • Investigate complex manufacturing product quality and compliance issues reported from the field, analyze results, determine root cause/probable cause, and initiate and review reports.
  • Coordinate and execute change control activities to support rapid innovation
  • Support design and development activities (i.e., engineering study, feasibility testing, drawing review, etc.)
  • Participate in escalation tasks and activities, including Project Risk Assessments (PRA)
  • Supports or leads test method development/validation activities for Design Verification testing and manufacturing inspections for NPD programs
  • Collaborate with R&D and Manufacturing organizations to facilitate the successful execution of the NPD process and launching of robust products
  • Develop complex experiments and tests (including writing and executing protocols) to create, improve, and validate products and manufacturing processes by analyzing results, making recommendations, and developing reports
  • Develop, update, and maintain technical content of risk management files
  • Develop training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes
  • Assign and oversee manufacturing support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician work
  • Other incidental duties assigned by Leadership
  • Ability to travel up to 10% domestically and internationally

What youll need (Required Qualifications):
  • Bachelors degree in Engineering or Scientific field with a minimum of (2) years of experience in either NPD, Quality Engineering, R&D, and/or Manufacturing; OR a Masters degree in Engineering or Scientific field with internship, senior projects, or thesis experience required.
  • Engineering experience within a highly regulated industry

What else we look for (Preferred Qualifications):
  • Experience in medical device (cardiovascular, endovascular, or other critical care/surgical products), healthcare, or a related environment preferred.
  • Knowledge and experience within Design Assurance, including Design Controls, Design Verification & Validation, Test Method Development, and Process Validation
  • Experience with root cause analysis or investigations for Complaints, NCRs, and/or CAPAs.
  • New Product Development experience from initial concept to commercialization (Class III preferred).
  • Experience with Risk Management and Design Control
  • Proven expertise in usage of MS Office Suite including MS Project
  • Basic understanding of statistical techniques
  • Strong problem-solving, organizational, analytical, and critical thinking skills

Education/Experience:
  • Bachelor's degree in engineering required.
  • 2-4 years experience 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.