Job Title: Software Quality Assurance

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

Job Description

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

Responsibilities

• 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 process, including the development and maintenance of risk management files, ensuring compliance with ISO.
• Develop and implement quality plans.
• Ensure post market surveillance reviews are conducted and reports documented according to schedule.
• Participate in CAPA efforts, and apply systematic problem-solving methodologies identifying, prioritizing, communicating, and driving 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.

Essential Skills

• Quality assurance
• Software quality assurance
• Validation
• Medical device
• Software testing
• Electrical engineering
• 5-8 years of experience within Software Quality Assurance
• Strong experience within ISO 6060-1 specifically the ISO 62-304
• Strong documentation work including risk assessments and change orders
• Bachelor's Degree

Additional Skills & Qualifications

• Technical guidance
• Oversight of Quality Engineers
• CAPA efforts
• Systematic problem-solving methodologies
• Regulatory audit support

Work Environment

This position will be fully remote with the occasional meeting or interaction with the team. The ideal candidate will be local to the Irvine area and able to come in whenever needed. You will be working with one other software engineer and two hardware engineers, collaborating closely on projects.

Pay and Benefits

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

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• 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 14, 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 : $65 - $75