Supplier Quality Specialist

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

• 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

• 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