Quality Compliance Specialist II

Actalent•Santa Clara, CA

45d•$30 - $32•Onsite

About The Position

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.

Requirements

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.

Nice To Haves

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

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.