Principal Quality Engineer

Job Title: Principal Quality Engineer

Job Description

We're seeking a Principal Quality Engineer to join our team and play a pivotal role in ensuring that our quality systems are impeccable. You will ensure that our products meet both regulatory and company standards, collaborating closely with various teams to ensure seamless and efficient operations.

Responsibilities

• Guide and oversee product and process validations, including sterilization validation and revalidation.
• Lead biocompatibility studies to ensure products meet necessary standards.
• Create and update Risk Management documents according to ISO standards 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 assist in maintaining Calibration and Preventive Maintenance Systems.
• Evaluate, develop, and monitor suppliers to ensure compliance with standards.
• Support the maintenance of the quality system in compliance with 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.
• 6 years of experience as a Quality Engineer within Medical Device or Biotechnology industries.
• Hands-on approach in quality management.
• Proficiency in design control, process validation, and biocompatibility.
• Experience in regulatory compliance and sterile processing.
• Skilled in root cause analysis, design validation, and CAPA.
• Familiarity with cleanroom environments and cardiovascular devices.
• Proficiency in Excel, particularly pivot tables.

Additional Skills & Qualifications

• Experience in biocompatibility is a must for Principal level.
• Experience with implantable medical devices is a plus.

Work Environment

The position involves working in a medical device manufacturing setting, primarily focused on cardiovascular devices. You will spend approximately 90% of your time at the Lake Forest site and 10% at the San Clemente site.

Job Type & Location

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

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 San Clemente,CA.

Application Deadline

This position is anticipated to close on Dec 15, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Salary : $140,000 - $200,000