Supplier Quality and Internal Auditor

Posting Date 3 weeks ago(7/6/2021 9:50 AM)
Requisition ID
2021-9237
Job Location(s)
Bloomington IN United States
Travel
20-30%
Position Type
Full Time
Company
Cook Medical Holdings
Category
Quality

Overview

The Supplier Quality and Internal Auditor assists with all aspects of the internal quality systems audit program including audit planning, execution, follow-up and re-audit if necessary. In addition the Supplier Quality and Internal Auditor will be involved in supplier qualification and monitoring of supplier quality.

Responsibilities

• Lead supplier audits including pre-audit supplier research, planning/coordination, report writing, and audit findings follow-up.
• Qualify new suppliers.
• Evaluate supplier change requests.
• Generate Supplier Corrective Action Requests (SCARs) including issuance, evaluation, and effectiveness monitoring as required and follow-up with suppliers for completion/closure.
• Monitor quality performance of suppliers
• Act as a liaison between suppliers, engineering, and manufacturing.
• Lead efforts to standardize auditor training programs for consistency in approach to auditing.
• Work with management and others as needed to establish internal audit schedule.
• Support management in the development and implementation of global policies/procedures

• Lead local and global internal audits of Cook Medical entities including pre-audit research, planning/coordination, report writing, and audit findings follow-up.
• Maintain competencies in regulations, standards, and policies/procedures.
• Provide information to support data trending and reporting.
• Must work and interact effectively and professionally with and for others throughout various levels of the global organization
• Must strictly adhere to safety requirements
• Maintain regular and punctual attendance
• Must maintain company quality and quantity 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

Qualifications

• BS or AS with a minimum of 3 years relevant experience
• In depth knowledge/ experience in the medical device industry
• High level of familiarity/ experience with medical device quality system regulations and standards
• Strong background in quality assurance

• Experience with third party audits
• Experience with leading audits

 

Physical Requirements:

• Willingness to travel up to 20% both domestically and internationally
• General office environment
• Sits for extended periods
• Close visual acuity for working with computers, etc.

• While performing the duties of this job, the employee is regularly required to stand; walk, and sit for extended periods of time

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