Quality Systems Specialist

The Quality Systems Specialist is responsible for the effective and accurate coordination of all quality documents within the Quality Management System. This role involves working in a medical device, regulated environment to coordinate the document control system and ensure compliance with both internal and external requirements.

Responsibilities

• Coordinate the change control processes.
• Support the execution of Corrective Actions (CAPA system).
• Support external audits.
• Adhere to policies and procedures pertaining to best documentation practices.
• Ensure documents are readily available in electronic format and accessible to all employees.
• Develop procedures and forms required for control of documentation and documentation activities.
• Manage electronic and hard-copy archival system for controlled documents.
• Oversee document changes and approvals.
• Manage part revision controls in the ERP Systems.
• Create and maintain documentation such as quality procedures and work instructions, including assignment of document numbers.
• Develop and provide metrics on the status of the change control process.
• Manage and control external documents.
• Support the training program, entering training data, monitoring completion, and preparing metrics.
• Assist with the performance and documentation of internal audits.
• Provide training on the procedure management process as required.
• Assign numbers for deviations, rework instructions, and engineering documentation.
• Oversee work assignments of the Document Control Assistant.
• Manage and maintain the training matrix and job by function report, notifying managers and supervisors when training is due.

• Experience with change controls, quality assurance, EQMS, and document control.
• Familiarity with CAPA, corrective actions, and quality systems.
• Experience in a medical device or manufacturing environment.
• Intermediate to advanced skills in MS Word and MS Excel.
• Proficiency with ERP systems software.

• Bachelor’s degree preferred but not required.
• Experience with technical documentation and the change order process.
• Ability to work under pressure and meet deadlines while maintaining a positive attitude and exemplary customer service.

The role is based onsite in a quality systems office cubicle at a fast-growing medical device manufacturer.

Job Type & Location

This is a Contract to Hire position based out of Newbury Park, CA.

The pay range for this position is $28.85 - $38.46/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)

This is a fully onsite position in Newbury Park,CA.

This position is anticipated to close on May 12, 2026.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is 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

Actalent is an equal opportunity employer.

About Actalent

Actalent is a global leader in engineering and sciences services. For more than 40 years, we’ve helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000 extraordinary employees who connect their passion with purpose every day.

Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.

Salary : $29 - $38