Doc Control Specialist

Quality Systems Specialist

We are seeking a Quality Management Systems Specialist who will be responsible for ensuring compliance with internal and external regulatory requirements, including but not limited to Site, Division, Corporate, FDA, ISO, MDD, and individual country requirements. This role involves engaging in the development of an optimum future state of QMS tailored to business needs, executing development and modification processes, and contributing to quality planning and management review forums.

Essential Skills / Must Have

• Document control and experience with medical device regulations.
• EU MDR, ISO, and CFR proficiency.
• Proficiency in quality systems and QMS.
• Understanding of ECOs and ECRs.
• Experience with medical device product development lifecycle, including risk management and design / process verification and validation.
• Knowledge of advanced quality tools such as FMEA, GD&T, root cause analysis, and mistake proofing / poke yoke.
• Ability to read and interpret CAD drawings.
• Experience in interacting with regulatory agencies such as FDA, MoH, and TUV.
• Thorough knowledge of US and international medical device regulations.
• Strong knowledge of quality concepts, including CAPA, audits, and statistics.
• Strong project management skills.
• Experience in working cross-functionally with departments such as advanced operations, product development, regulatory affairs, and marketing.
• Experience in managing and completing projects in a matrix organization.
• Ability to work independently.
• Experience in compliance risk situations.
• Computer literacy, including proficiency with Mini-Tab or similar analysis programs.

Responsibilities

Work Environment

The work environment is dynamic and encourages professional growth. Employees are provided with 2 weeks of PTO and 10 paid holidays. The role involves collaboration with various departments, utilizing advanced technologies and methodologies to maintain regulatory compliance and product quality. Dress code adheres to professional standards.

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 :

Workplace Type

This is a fully onsite position in Irvine, CA.

Application Deadline

This position is anticipated to close on Oct 31, 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.