Job Title: Software Design Assurance Quality Engineer

*This position is remote but the candidate MUST be local to the Irvine area*

Company Overview:

Global medical device company that develops and delivers innovative lifesaving products and software solutions to EMS, hospital, public safety, and military customers worldwide is seeking a Senior Design Assurance Quality Engineer (Software). Their products include AEDs, trauma kits, ventilators, temperature management solutions, and more. Our dedicated employees take pride in their commitment to improving patient outcomes while delivering world-class customer service.

Job Summary:

This position is responsible for supporting electrode product and process sustaining activities through the application of Quality engineering skills for medical devices. The role focuses on process, equipment, and design verification and validations; working with teams to develop manufacturing and quality processes and define their related tools; troubleshooting and support of manufacturing floor and field issues, and review and approval of validations.

Essential Functions:

Review and approve verification and validation protocols and reports.Participate in Change Control review and approval activities as required.Provide technical guidance and oversight to Quality Engineers.Participate in Risk Management processes, including the development and maintenance of risk management files, ensuring compliance with ISO 14971.Develop and implement quality plans.Ensure post-market surveillance reviews are conducted and reports documented according to schedule.Participate in CAPA efforts, applying systematic problem-solving methodologies to identify, prioritize, communicate, and drive resolution of quality issues.Provide key quality trending information and data for Management Review and monthly KPI review, as applicable.Represent quality interests and concerns on project teams.Investigate causes of quality and yield problems identified in the field and throughout the manufacturing and testing processes.Provide critical quality engineering direction to projects with respect to generally accepted quality engineering tools/principles, such as process validation, equipment, test methods, root cause analysis, risk mitigation, process improvement tools, sampling plans, etc.Provide support during regulatory audits and responses to government agency questions.

Required/Preferred Education and Experience:

Bachelor's Degree in Engineering or a technical discipline required.5 years of medical device experience required.

Knowledge, Skills, and Abilities:

Proficient with Microsoft Office Suite.Familiarity with mechanical and electrical test equipment.Knowledge of commonly used concepts, practices, and procedures related to medical device manufacturing.Working knowledge of EN ISO 13485, ISO 14971, and FDA QSR for Medical Devices.Ability to work in a fast-paced environment.High-energy problem solver capable of driving items to closure.Excellent communication and interpersonal skills (verbal, written, and presentation). Understands how to present information dependent on the level of the audience.Ability to effectively manage time, balance multiple task assignments, and translate quality requirements into product specifications.Understands basic applied statistics, statistical sampling plans, and statistical process control.Familiar with Minitab Statistical Analysis Software (or equivalent).
Pay and Benefits

The pay range for this position is $65.00 - $75.00

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully remote position.

Application Deadline

This position will be accepting applications until Jan 24, 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.