Quality Engineer

Quality Engineer

We are seeking two mid-level Quality Engineers or a Principal Quality Engineer to join our team. This role is essential in maintaining a top-notch quality system and ensuring our products meet all regulatory and company standards. You will collaborate closely 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 biocompatible.
• Create and update Risk Management documents as per ISO for new products or design changes.
• Represent Quality Assurance on project teams for new or revised products.
• Investigate product or production issues and develop corrective actions.
• Oversee and help maintain our Calibration and Preventive Maintenance Systems.
• Evaluate, develop, and monitor suppliers to ensure they meet our standards.
• Support the maintenance of our quality system in compliance with our Quality Policy and regulatory standards.
• Provide support for regulatory submissions and audits.
• Have signature authority for changes to manufacturing/quality procedures, processes, and designs.
• Provide training and direction for Quality Inspectors and Technicians.

Essential Skills

• Quality assurance experience in medical devices.
• Proficiency in risk management and ISO standards.
• Sterilization validation expertise.
• Bachelor's degree required.
• 5+ years of experience as a Quality Engineer within the Medical Device or Biotechnology industry.

Additional Skills & Qualifications

• Hands-on approach in quality and biocompatibility.
• Experience with Cleanroom environments.
• Knowledge of cardiovascular devices and regulatory compliance.
• Proficiency in design control, process validation, and CAPA.
• Experience with quality management systems, including Arena.
• Ability to perform root cause analysis and design validation.
• Experience with implantable medical devices is a plus.
• Biocompatibility experience is a must for the Principal level.
• Proficiency in using Excel pivot tables.

Work Environment

The role is based in a medical device manufacturing setting for cardiovascular devices. You will spend 90% of your time at our Lake Forest site and 10% at our San Clemente site. The company is focused on developing innovative technologies for treating cardiovascular disease and has recently received FDA approval for commercialization.

Job Type & Location

This is a Permanent position based out of San Clemente, California.

Pay and Benefits

The pay range for this position is $140,000.00 - $200,000.00/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 San Clemente, CA.

Application Deadline

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