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Sr Quality Engineer
1851 East Deere Avenue Santa Ana, CA 92705 US
Job Description
As a Quality Engineer you will play a key role in ensuring that products and processes comply with regulatory and the companies standards. You’ll collaborate cross-functionally to drive continuous improvement, support manufacturing, and ensure the highest levels of product quality and patient safety. The role includes hands-on support in controlled environments, involvement with animal-origin tissue, and active participation in daily production activities.
Key Responsibilities:
• Provide quality engineering support for manufacturing, sustaining, and new product introduction.
• Participate in daily manufacturing tier meetings to support production and address quality-related concerns.
• Be present in controlled environment areas/clean rooms to monitor processes, support investigations, and ensure compliance with quality standards.
• Work with tissue from animal origin (porcine and bovine) in accordance with safety and regulatory requirements.
• Investigate product non-conformances and implement corrective and preventive actions (CAPA).
• Lead or participate in process validation activities (IQ/OQ/PQ).
• Ensure compliance with FDA QSR, ISO 13485, and other applicable regulations.
• Review and approve process and product changes.
• Analyze data, conduct risk assessments, and support root cause analysis.
• Lead or support internal and external audits.
• Participate in the development and review of quality documentation (procedures, protocols, reports).
Minimum Requirements:
• Bachelor’s degree in Engineering, Science, or related technical field.
• 4+ years of experience in Quality Engineering or a related field in the medical device or regulated industry.
• Experience with Nonconformance material reports, CAPAs, and FMEA.
• Able to work with Bovine and Porcine tissue.
• Working knowledge of FDA regulations and ISO 13485.
Preferred Qualifications:
• Experience with CAPA, risk management (FMEA), and process validation.
• ASQ certification (CQE, CQA) a plus.
• Strong communication and teamwork skills.
• Experience with statistical analysis and data interpretation.
Pay ranges between 48-53/hr based on experience
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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