Quality Systems Specialist

Job Title: Quality Systems Specialist

Job Description

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.

Essential Skills

• 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.

Additional Skills & Qualifications

• 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.

Work Environment

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.

Pay and Benefits

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)

Workplace Type

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

Application Deadline

This position is anticipated to close on Jun 19, 2026.

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.

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.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.