Job Title: Senior Quality Engineer

Job Description

We're looking for a Principal Quality Engineer to join our team. This role is crucial in ensuring that our quality system is top-notch and that our products meet all regulatory and company standards. You'll be working closely with various teams to make sure everything runs smoothly and efficiently.

Responsibilities

• Guide and oversee product and process validations, including sterilization validation and revalidation.
• Lead studies to ensure our products are biocompatible.
• Create and update Risk Management documents as per ISO standards for new products or design changes.
• Represent Quality Assurance on project teams for new or revised products.
• Investigate any 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
• Medical device experience
• Risk management
• ISO standards
• Sterilization
• Bachelor's degree
• 7 years as Quality Engineer within Medical Device or Biotechnology sectors
• Hands-on approach in quality management
• Experience in leading and training quality teams
• Biocompatibility
• Cleanroom experience
• Cardiovascular device experience
• Audit processes
• Design control
• Process validation
• Excel pivot tables
• Regulatory compliance
• Sterile processing

Additional Skills & Qualifications

• Experience in biocompatibility is a plus
• Experience with implantable medical devices

Work Environment

The team includes 2 Quality Engineers and 3 Technicians, with a larger team that includes both women and men. The company focuses on developing innovative technologies for treating cardiovascular disease and collaborates closely with physicians to design and improve medical devices that address unmet clinical needs. They offer a range of vascular intervention devices, including Wingman Catheters, Spex and Spex LP, Spur Stent, and various Cora catheter-based solutions.

Pay and Benefits

The pay range for this position is $140000.00 - $200000.00/yr.

Employee Benefits include but are not limited to:
Health Benefits: Medical, dental, and vision coverage.
Disability and Retirement: Options for disability insurance and retirement plans.
Work-Life Balance: Opportunities for maintaining a balance between home and career.
Team Building: On-site team building activities and community volunteer projects.
Inclusion: A diverse workforce where inclusion is valued and practiced

Workplace Type

This is a fully onsite position in San Clemente,CA.

Application Deadline

This position is anticipated to close on Apr 29, 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.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

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 process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Salary : $140,000 - $200,000