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Job Title: Quality Engineer

Job Description

We are seeking two mid-level Quality Engineers or a Principal Quality Engineer to join our dynamic team. This role is pivotal in ensuring that our quality system is exceptional and that our products meet all regulatory and company standards. You will work 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 product safety.

+ Create and update Risk Management documents for new products or design changes as per 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 Calibration and Preventive Maintenance Systems.

+ Evaluate, develop, and monitor suppliers to ensure compliance with our standards.

+ Support the maintenance of the 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.

Essential Skills

+ 5+ years of experience as a Quality Engineer within the Medical Device or Biotechnology industry.

+ Hands-on approach to quality, biocompatibility, and cleanroom environments.

+ Experience in cardiovascular, audit, regulatory compliance, and sterile processing.

+ Proficiency in quality engineering, root cause analysis, design validation, and CAPA.

+ Strong understanding of quality management systems and new product development.

+ Bachelor's degree required.

Additional Skills & Qualifications

+ Experience in biocompatibility is a must for Principal level.

+ Experience with implantable medical devices is a plus.

+ Proficiency in Excel pivot tables and using Arena.

Work Environment

This position is within a medical device manufacturing environment focused on cardiovascular devices. Join a private company dedicated to developing innovative technologies for treating cardiovascular disease, recently approved by the FDA for commercialization. Collaborate with physicians to design and improve medical devices, offering a range of vascular intervention devices.

Job Type & Location

This is a Permanent position based out of Lake Forest, 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:MedicalDentalVisionPTO, Holiday CA Sick PayAdditional employee benefit options

Workplace Type

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

Application Deadline

This position is anticipated to close on Nov 30, 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.