Quality Compliance Specialist II

Overview

Ensure compliance with FDA, MDD/MDR, ISO; manage audits, NCRs, and quality metrics.

Key Responsibilities

• audit coordination
• qms improvement
• ncr management
• service orders
• metrics trending
• supplier management

Tasks

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

Requirements

• cgmp
• fda 820
• iso
• ms excel
• capa
• bachelor’s

What You Bring

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

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Benefits

-Medical, dental & vision -Health Spending Account (HSA) -Short and long-term disability -Critical Illness, Accident, and Hospital -Time Off/Leave (PTO, Vacation or Sick Leave) -401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available -Employee Assistance Program -Life Insurance (Voluntary Life & AD&D for the employee and dependents) -Transportation benefits

About Actalent

-Born in July 2021 by merging Aerotek’s engineering & sciences arm with EASi, Actalent emerged as a focused engineering-and-science partner. -Backed by Allegis Group, it drives scale and speed to market via contract, managed, and technical services. -Headquartered in Maryland with global reach, it deploys specialized teams across North America, Europe, and APAC on Fortune 500 projects. -Typical engagements span EV design, vaccine development, lab services, clinical research, and infrastructure systems. -Expertise covers a wide spectrum: aerospace, defense, healthcare, manufacturing, software systems, environmental and civil engineering.

Sector Specialisms