Quality Engineer

Quality Engineer

We are seeking two mid-level Quality Engineers or a Principal Quality Engineer to join our team. This role is pivotal in ensuring our quality system meets top standards and that our products comply with regulatory and company guidelines. You will collaborate with various teams to ensure smooth and efficient operations.

Responsibilities

• Guide and oversee product and process validations, including sterilization validation and revalidation.
• Lead biocompatibility studies to ensure our products are safe.
• Create and update Risk Management documents for new products or design changes, adhering to ISO standards.
• Represent Quality Assurance on project teams for new or revised products.
• Investigate product or production issues and develop corrective actions.
• Oversee and maintain our Calibration and Preventive Maintenance Systems.
• Evaluate, develop, and monitor suppliers to ensure compliance with standards.
• Support the maintenance of our quality system in line with our Quality Policy and regulatory standards.
• Provide support for regulatory submissions and audits.
• Hold signature authority for changes to manufacturing/quality procedures, processes, and designs.
• Provide training and direction for Quality Inspectors and Technicians.

Essential Skills

• Bachelor's degree required.
• 5+ years of experience as a Quality Engineer within the Medical Device or Biotechnology field.
• Expertise in risk management, ISO standards, sterilization, and quality engineering.
• Hands-on approach in quality assurance, biocompatibility, cleanroom management, and cardiovascular device development.
• Proficiency in regulatory compliance, design control, process validation, and root cause analysis.

Additional Skills & Qualifications

• Experience in biocompatibility is a must for the Principal level.
• Experience with implantable medical devices is a plus.
• Proficiency with Excel pivot tables, sterile processing, quality management systems, and design validation.

Work Environment

The role is based in medical device manufacturing for cardiovascular devices, with 90% of the time spent at the Lake Forest site and 10% at the San Clemente site. The position involves collaborating with a team dedicated to developing innovative vascular intervention devices, including catheters and stents.

Job Type & Location

This is a permanent position based out of Lake Forest and San Clemente, California.

Pay and Benefits

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.

Workplace Type

This is a fully onsite position in Lake Forest, CA.

Application Deadline

This position is anticipated to close on Oct 23, 2025.