Quality Audit Technician

Corning•Tewksbury, MA

2d•$58,236 - $80,075•Onsite

About The Position

This role will support the division quality auditing team to ensure quality system compliance with applicable ISO and regulatory requirements. This role will provide administrative support to quality auditing programs, act as a support auditor in internal audits, and manage audit related documents and records.

Requirements

Associate’s degree
2-4 years of experience working in an ISO certified environment such as ISO 9001 (experience working in an ISO 13485, GMP, or other regulated manufacturing environment is preferred).
Proficient with Microsoft Office Applications
Must be detail oriented and accurate
Effectively, positively & professionally interact with internal and external customers
Previous experience working in an electronic quality management system software preferred (such as ETQ or Trackwise)

Responsibilities

Responsible for reviewing quality management system records for completeness, compliance, and good documentation practices.
Manages and organizes quality audit related records. Processes records through DocuSign.
Prepares documents and records for customer audits, ISO certification audits, and regulatory body inspections. Provides administrative support for all audit activities such as acting as audit scribe, establishing external SharePoint sites, and logging records.
Participates as a supporting auditor for the internal audit program.
Initiates Change Controls and Document Change Requests to update audit related procedures and processes.
Assists to manage databases for tracking/trending audit related activities and metrics.
Assists to manage Approved Supplier List (ASL). Tracks requests for supplier assessments and changes to the ASL.
Assists to gather supplier performance data from all CLS sites.
Works with vendors to complete supplier quality assessments and collect supplier information such as ISO certificates.
Processes customer audit requests and assist customers to fulfil their supplier management requirements. Escalates customer issues immediately.
Completes other administrative duties as assigned.
Travel requirements: up to 25%