Supplier Quality Specialist

Posting Date 4 weeks ago(2/10/2021 8:15 AM)
Requisition ID
2021-8517
Job Location(s)
Bloomington IN United States
Travel
20-30%
Position Type
Full Time
Company
Cook Medical Inc.
Category
Quality

Overview

The Supplier Quality Specialist at Cook Medical is responsible for assisting with performance of supplier qualification and monitoring of supplier quality.

Responsibilities

• Lead supplier audits including pre-audit supplier research, planning/coordination, report writing and audit finding follow up
• Author and perform investigations (Deviations/Non-conformances) ensuring proper Root Cause Analysis
• Represent Quality during internal and external audits as a subject matter expert
• Ensure Cook Medical LLC (CMLLC) is inspection ready at all times
• Support and perform change management activities, e.g. conducting change board meetings, reviewing change for impact to validated state, reviewing change for impact to established QMS
• Support Quality Management Review data collection and analysis
• Review documentation to ensure compliance with established QMS
• Perform gap analysis
• Participate in Continuous Improvement activities
• Perform trending of quality data, ensuring proper application of CAPA and feedback loops are effective
• Independently produce, organize, and maintain documentation or systems critical to the function of supplier quality
• Identify quality issues and generate Supplier Corrective Action Requests
• Qualify new suppliers and monitor the supplier qualification process through data trending and reporting
• Understand and able to apply ISO13485 and other regulatory requirements within a distribution and import environment
• Understand and able to apply principles of good practices pertaining to warehousing and distribution
• General research, documentation, and file/ database maintenance
• Lead and/or support various supplier-related quality projects
• Prepare and maintain accurate and timely documentation consistent with the requirements of pertinent regulations and Cook’s Quality Management System where applicable
• Negotiate quality agreement terms

Qualifications

• Bachelor's degree in a technical field; or experience of such kind and amount as to provide a comparable background
• 3-5 years of experience in Quality
• 2 years of experience within a GxP environment

• Must have good internet connection for daily communications and interactions with team

• Experience with TrackWise, electronic document control systems
• Knowledge of medical device regulations, including pertinent standards and guidances, preferred or demonstrated regulatory knowledge in similarly regulated industry
• Project management experience preferred
• Knowledge of Cook Medical LLC's quality systems preferred
• Experience with jBase,TrackWise and Business Objects preferred
• Auditor certification (ASQ or equivalent) is preferred

• Qualified candidates must be legally authorized to be employed in the United States. Cook does not intend to provide sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position

 

Physical Requirements:

• Sitting for extended periods, utilizes close visual acuity for working with computers, etc.
• Works under general office environmental conditions
• Frequently required to stand, walk, use hands to grasp, carry, feel or touch; reach with hands and arms; talk and hear
• Travel up to 20%, including international travel

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