Job Information
Actalent Quality Compliance Specialist II in Santa Clara, California
Job Title: Quality Compliance Specialist IIJob Description
Position Overview In compliance with FDA, European MDD/MDR & ISO regulations, the Quality Compliance Specialist will perform work under supervision. The general scope of this position is to support the NCR process, data analysis, internal and external audits, service order records, supplier files, and monitoring of key process metrics. This position requires frequent use and general knowledge of industry practices, techniques, and standards. Essential Job Functions - Assist with audit activities. - Participate in quality system activities and support internal and external audits. - Coordinate audit-related activities (prepare documents, track audit requests, take notes, schedule conference rooms, set up communication channels, etc.). - Interface with Subject Matter Experts regarding audit requests. - Assist with managing the NCR/Rework/Deviation System. - Work cross-functionally with other teams to track and manage NCR/Rework/Deviation activities from initiation through closure. - Assist with affected product identification, segregation, investigation, and final disposition. - Identify and implement QMS system continuous improvement activities. - Maintain records per procedure requirements. - Assist with Supplier Controls. - Initiate and maintain supplier files on the Approved Supplier List. - Gather information and update as needed to ensure supplier files are current and in compliance with supplier procedures. - Manage Service Orders Request (SOR). - Keep a record of the SOR activities. - Ensure that the NCR materials are managed to comply with 30 days post-receipt requirements. - Maintain the full record of all the SOR repairs and costs associated with repairs. - Compile quality metrics for trending purposes. - Develop, implement, and maintain SOR data logs. - Compile data and prepare presentations as needed for periodic reviews of the following Quality systems: SORs, Costs per SOR, etc. - Work cross-functionally with other teams to compile and generate periodic reports in a timely manner to support quality systems activities. - Work cross-functionally with other teams in tracking and ensuring Quality Objectives published during Management Reviews are met. - Support company goals and objectives, policies, and procedures, QSR, and FDA regulations. - Other duties as assigned.
Hard Skills
NCR
Quality Control
Quality Systems
Job Type
This is a Contract-to-Hire position with a duration of 6 Month(s).
Work Site
This is a fully on-site position in Santa Clara, California.
Work Environment
Collaborative working with an immediate 2 team members and an additional 2-3 cross-functionally.
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.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are 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
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 (%20actalentaccommodation@actalentservices.com) for other accommodation options.