Lead Quality Auditor

Posting Date 3 months ago(3/3/2022 6:26 AM)
Requisition ID
2022-10427
Job Location(s)
Bloomington IN United States
Shift Type
First
Position Type
Full Time
Company
Cook Inc.
Category
Quality

Overview

The Quality System Lead Auditor assists with all aspects of the internal quality system audit program including audit planning, execution, audit reports , follow-up and re-audit if necessary.

Responsibilities

• Fully understand the requirements of the Quality Management System
• Ensure that quality policies and procedures are being adhered to by
various departments
• Provide internal communication regarding compliance issues and
applicable regulation changes.
• Aid in creation of gap analysis to any new/changed regulations
• Communicate to management issues that require corrective action
• Maintain files generated from each audit
• Responsible for on-site and off site audit of Quality Management System
• Plan, execute and prepare audits as assigned and complete audit report and follow up actions

• Must work and interact effectively and professionally with and for others
throughout various levels of the global organization
• FDA or Notified Body experience strongly preferred.
• Must maintain company quality and performance standards
• Must have effective oral and written communication skills
• Excellent problem solving skills and ability to work in collaborative and
independent work situations and environments with minimal supervision
• Ability to remain calm and receptive in fast paced situations
• Medical Device regulations knowledge and experience is required.

Qualifications

• Bachelor's degree in related field (Engineering, STEM)
• High degree of familiarity with ISO 13485 and 21 CFR 820
• At least seven years of experience in a Quality role with at least two years in quality audit required

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