Document Control Specialist

Job Title: Document Quality Control Specialist

We are seeking a dedicated Document Quality Control Specialist responsible for ensuring compliance with both internal and external regulatory requirements. This role involves contributing to the development and optimization of Quality Management Systems (QMS) to meet business needs and regulatory standards.

Responsibilities

• Ensure QMS compliance with site, division, corporate, FDA, ISO, MDD, and individual country requirements.

• Engage in the development of an optimal future state of QMS for business needs.

• Provide improvements and inputs into the quality planning process.

• Execute the development and/or modification of the QMS.

• Participate in Management Review, Quality Planning Review, and related forums.

• Assess and quantify requirements for optimizing QMS structure.

• Ensure GMP and GDP compliance within the Quality organization.

• Identify and implement improvement opportunities to enhance the efficiency and effectiveness of the QMS.

• Contribute to the development, maintenance, and improvement of policies and procedures.

• Implement best-in-class practices and benchmark against industry leaders and regulatory requirements.

• Facilitate communication with notified bodies.

• Ensure QMS reflects actual activities and business needs, and supports NPD requirements.

• Participate in relevant QMS IS discussions.

• Act as a key contributor to QMS business processes and understand IS system support requirements.

• Participate in internal and external quality system audits.

• Understand system integration and IS change control assessment and approval.

Essential Skills

• Experience with medical device product development lifecycle, including risk management and design/process verification and validation.

• Applied knowledge of Advanced Quality tools such as Failure Modes Effect Analysis (FMEA), GD&T, Root Cause Analysis, and Mistake Proofing/Poke Yoke.

• Ability to read and interpret CAD drawings.

• Experience interacting with regulatory agencies (FDA, MoH, TUV, etc.).

• Thorough understanding of US and International Medical Device Regulations.

• Strong knowledge of Quality Concepts such as CAPA, Audits, and Statistics.

• Strong project management skills and the ability to manage multiple tasks simultaneously.

• Ability to advocate for product excellence and quality.

• Effective cross-functional collaboration skills with departments including Advanced Operations, Product Development, Regulatory Affairs, and Marketing.

• Strong interpersonal, written, oral communication, and negotiation skills.

• Critical and analytical thinking skills.

• Ability to manage and complete projects in a matrix organization.

• Ability to work independently.

• Experience working in compliance risk situations.

• Computer literacy, including proficiency with Mini-Tab or similar analysis programs.

Additional Skills & Qualifications

• Knowledge of document control, QMS, ECOs, ECRs, Medical Device, and Quality Systems.

• Experience as a Configuration Specialist or in Doc Control.

• Knowledge of Medical Device Regulations.

Work Environment

The work environment includes a structured setting where you will engage with advanced technologies and adhere to specific regulatory requirements. Benefits include 2 weeks of PTO and 10 paid holidays.

Job Type & Location

This is a position based out of Irvine, California.

Pay and Benefits

The pay range for this position is $40.00 - $55.00/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 Oct 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.

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 due to a disability, please email (% ) for other accommodation options.