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Hiring a Quality Engineer for an immediate opening!

For immediate consideration please apply to this position and email your resume to [email protected]

Job Description

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 $140000.00 - $200000.00/yr.

Internal employee benefits include but are not limited to:MedicalDentalVisionPTO, Holiday CA Sick PayAdditional 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.

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 [email protected] (%[email protected]) for other accommodation options.