Quality Compliance Specialist II

The Quality Compliance Specialist will play a pivotal role in ensuring compliance with FDA, European MDD/MDR, and ISO regulations. This position supports various quality system activities, including NCR processes, data analysis, and audits, under supervision. The role requires frequent interaction with industry practices, techniques, and standards.

Responsibilities

• Participate in quality system activities and support internal and external audits.
• Coordinate audit-related activities, including document preparation, tracking audit requests, and setting up communication channels.
• Interface with Subject Matter Experts regarding audit requests.
• Manage NCR/Rework/Deviation activities from initiation through closure by working cross-functionally with other teams.
• Assist with affected product identification, segregation, investigation, and final disposition.
• Implement QMS system continuous improvement activities and maintain records per procedure requirements.
• Initiate and maintain supplier files on the Approved Supplier List, ensuring compliance with procedures.
• Manage Service Orders Request (SOR) and maintain records of all SOR repairs and associated costs.
• Compile quality metrics for trending purposes and prepare presentations for periodic reviews.
• Work cross-functionally to compile and generate periodic reports to support quality systems activities.
• Track and ensure Quality Objectives published during Management Reviews are met.
• Support company goals and objectives, policies, procedures, QSR, and FDA regulations.

• Bachelor’s degree and a minimum of 2 years of related experience in the medical device industry.
• Experience with FDA/ISO Audits, NCR, and CAPA is a plus.
• Ability to compile and analyze data, present information, and demonstrate competent document writing skills.
• Excellent written and verbal communication skills.
• Basic knowledge of cGMP, FDA 820 QSR, and ISO or other Quality Systems.
• Ability to understand and follow QMS Procedures, such as SOP and Test Methods.
• Experience with computer-based applications like MS Word, MS Excel, and PowerPoint.
• Strong time management skills and ability to multi-task in a fast-paced environment.

• Operate as a team and/or independently while demonstrating flexibility to changing requirements.

The work environment is collaborative, involving immediate collaboration with two team members and cross-functional interaction with an additional two to three team members.

Job Type & Location

This is a Contract to Hire position based out of Santa Clara, CA.

Pay and Benefits

The pay range for this position is $30.00 - $32.00/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 Santa Clara,CA.

Application Deadline

This position is anticipated to close on Dec 5, 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 actalentaccommodation@actalentservices.com for other accommodation options.

Salary : $30 - $32