Sr Quality Engineer

1 week ago

Santa Ana, CA, United States LanceSoft Full time

Join our team in Santa Ana, CA, a vibrant location known for its rich culture and proximity to beautiful Southern California beaches. As a key member of our Quality Engineering team, you will play a crucial role in ensuring the highest standards of product quality and patient safety in the medical device industry.

Position Overview

As a Quality Engineer at our Santa Ana facility, you will collaborate cross-functionally to drive continuous improvement, support manufacturing, and ensure compliance with regulatory standards. Your role will involve hands-on support in controlled environments, working 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.

Location

Santa Ana, CA (onsite)

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