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Quality Engineer
1441 McGaw Avenue Irvine, CA 92614 US
Job Description
*Depending on experience
Summary:
This Quality Engineer will support the Pilot Quality Engineering team for the Pilot Operations a part of Global Supply Chain. This cross functional partner will (1) interact with various functional departments to accomplish compliance and implementation of quality goals within Pilot Manufacturing, (2) work with new product development teams in the manufacturing of products for feasibility studies, quality system test samples, Early Human Use, and clinical studies and (3) support product transfer from Pilot Manufacturing to receiving site manufacturing facilities.
Key Responsibilities:
• Work with new product development teams (Implants, Delivery Systems and/or Accessories) to help them efficiently navigate the Quality System in order to build quality system test samples and human use product according to project schedules
• Identify and ensure implementation of opportunities to optimize/improve manufacturing and inspection processes
• Perform risk assessment on early-stage product manufacturing processes (e.g., PFMEAs, Live Manufacturing Process Reviews)
• Analyze and resolve complex manufacturing and compliance issues (e.g., CAPA, non-conformances, audit observations)
• Develop/drive improvements for inspection test methods
• Lead test method validation activities for in-process inspections
• Facilitate and oversee Material Review Board to disposition potentially non-conforming human use products
• Track product yields and defect rates. Use data to report metrics at Quality Data Reviews and drive process improvements
Education/Experience:
• Bachelor's degree in engineering required.
• 5-7 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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