Jobs for People with MS: National MS Society

Job Title: Quality Assurance EngineerJob Description

Provide technical expertise and guidance for all activities associated with QC Sterilization to support operational efficiency and compliance. Manage activities related to validating and revalidating sterilization equipment, methods, and products in accordance with industry standards and regulations. This includes developing master plans, maintaining project schedules, and developing, reviewing, and approving validation protocols and reports. Write and conduct investigations related to quality issues, ensuring thorough documentation and resolution. Run and participate in various review boards, including MRB (Material Review Board), microbiology, quality, and way mix boards. Oversee the quality aspects of facilities and utilities, ensuring compliance with relevant standards and regulations. Conduct risk assessments and develop impact rationales for sterilization processes. Implement and manage corrective actions to address quality issues and prevent recurrence.

Responsibilities

• Provide technical expertise and guidance for QC Sterilization activities.

• Manage validation and revalidation of sterilization equipment, methods, and products.

• Develop master plans, maintain project schedules, and develop, review, and approve validation protocols and reports.

• Write and conduct investigations related to quality issues.

• Run and participate in various review boards (MRB, microbiology, quality, and way mix boards).

• Oversee the quality aspects of facilities and utilities.

• Conduct risk assessments and develop impact rationales for sterilization processes.

• Implement and manage corrective actions to address and prevent quality issues.

Essential Skills

• Sterilization

• Quality assurance

• Medical device industry experience

• 8+ years of experience conducting quality investigations with thorough documentation

• 2+ years of experience in sterilization

• Experience in medical device or pharma quality engineering

• Experience with corrective action plans

• Experience in validation processes

Additional Skills & Qualifications

• Bachelor's degree (engineering preferred)

• 8+ years of experience in quality assurance within medical device or pharma industry

• Ownership of sterilization processes

Work Environment

The work environment is dynamic and fast-paced, reflecting the high standards and demands of the medical device industry. This is an onsite role with working hours from 8am to 5pm. The position requires cross-functional collaboration with several departments and will be highly visible within the organization.

Pay and Benefits

The pay range for this position is $65.00 - $66.00/hr.

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 onsite position in Irvine,CA.

Application Deadline

This position is anticipated to close on Apr 25, 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 (%20actalentaccommodation@actalentservices.com) for other accommodation options.