Senior Quality Data Analyst

Posting Date 1 month ago(10/27/2020 7:48 AM)
Requisition ID
2020-8019
Job Location(s)
Bloomington IN United States
Travel
20-30%
Position Type
Full Time
Company
Cook Inc.
Category
Quality

Overview

The Senior Quality Data Analyst at Cook Medical works with subject matter experts, process owners, subsystem leaders, management with executive responsibilities, and IT to execute quality system planning, processes, verification, analysis, and reporting methods while promoting a collaborative atmosphere of quality awareness and continuous improvement.

Responsibilities

• Plan, document and participate in external audits performed by third parties, such as regulatory authorities
• Compile, analyze and distribute reports regarding compliance, quality measures and business metrics
• Maintain electronic files and/or hard copies and manage Management Review meeting minutes and data supporting Management Review
• Prepare and maintain accurate documentation consistent with the requirements of pertinent regulations and COOK's Quality Management System, where applicable
• Perform quality system audits
• Support quality system activities including non-conformance investigations, CAPA execution/ sponsorship, and supplier evaluations
• Drafting/ executing quality plans
• Prepare change orders, as needed
• Working knowledge and understanding of all COOK Medical Management System Procedures. Purchasing, Quality, engineering, manufacturing, document control

• General research, documentation, and file/database maintenance
• Working knowledge and understanding of ISO 13485 regulations and 21CFR820 Quality System Regulations
• Application of process control methodologies and statistical analysis of quality data
• Leadership/mentoring of quality data analysts

Qualifications

• Minimum 8-10 years relevant experience Quality Assurance or Data Analytics
• Bachelor's Degree or equivalent in a technical discipline or experience of such kind and amount as to provide a comparable background
• Working knowledge of medical device regulations, including pertinent standards and guidances, preferred or demonstrated regulatory knowledge in similarly regulated industry
• Project Management experience preferred

• Auditing certification preferred
• Knowledge of Cook Inc. quality system, associated documentation, and product lines preferred or demonstrated medical device (or similar industry) quality system knowledge
• Experience in statistical and analytical reasoning
• Computer literacy and proficiency
• Data analysis software experience required (e.g. Minitab, JMP, etc.)

 

Physical Requirements:

• Works under general office environment conditions
• Sitting for extended periods
• Utilizes close visual acuity for working with computers and equipment
• Frequently required to stand, walk, and communicate
• Frequently required to lift between 20 and 50 pounds throughout the workday
• Travel up to 30%

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