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Quality Engineer II
1441 McGaw Avenue Irvine, CA 92614 US
Job Description
*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.
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The 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, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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