Quality Engineer

Senior Or Principal Quality Engineer

We're looking for a senior or principal quality engineer to join our team. This role is crucial in ensuring that our quality system is top-notch and that our products meet all regulatory and company standards. You'll be working closely with various teams to make sure everything runs smoothly and efficiently.

Product and process validation: You'll guide and oversee product and process validations, including sterilization validation and revalidation.

Biocompatibility studies: Lead studies to ensure our products are biocompatible.

Risk management: Create and update risk management documents as per ISO 14971 for new products or design changes.

Design control: Represent quality assurance on project teams for new or revised products.

Issue investigation: Investigate any product or production issues and develop corrective actions.

System maintenance: Oversee and help maintain our calibration and preventive maintenance systems.

Supplier management: Evaluate, develop, and monitor suppliers to ensure they meet our standards.

Quality system support: Support the maintenance of our quality system in compliance with our quality policy and regulatory standards.

Regulatory support: Provide support for regulatory submissions and audits.

Authority on quality changes: Have signature authority for changes to manufacturing/quality procedures, processes, and designs.

Training and direction: Provide training and direction for quality inspectors and technicians.

Quality assurance, medical device, risk management, iso 14971, sterilization, biocompatibility, cleanroom, cardiovascular, audit, design control, process validation, FDA, excel pivot tables, regulatory, regulatory compliance, sterile processing.

Quality assurance, medical device, risk management, iso 14971, sterilization.

Experience in biocompatibility a plus.

Implantable medical device experience.

Intermediate level.

The pay range for this position is $140000.00 - $200000.00/yr.

Internal employee benefits include but are not limited to: medical, dental, vision, pto, holiday, ca sick pay, additional employee benefit options.

This is a fully onsite position in San Clemente, CA.

This position is anticipated to close on Oct 22, 2025.