Specialist, Quality Systems Data Analyst

The Quality Systems Analyst is responsible for working with subject matter experts, process owners, subsystem leaders, management with executive responsibilities and IT in helping to execute quality system planning, processes, verification, analysis and reporting methods while promoting a collaborative atmosphere of quality awareness and continuous improvement.

Position will focus on application of process control methodologies and statistical analysis of quality data with ability to support any of the following responsibilities:
• Enforce compliance through documented analysis of quality system and regulatory requirements.
• Plan 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.
• Support quality planning preparation, tracking and execution.

• Administrator of Cook Learn, assist with training curriculum, providing management of late training.

• Ensure that issues requiring action are identified, action is verified for implementation and effectiveness, and fed to CAPA system, as appropriate.
• Must maintain all training requirements for the position, while seeking out opportunities for continuous development and growth.
• Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements.

• Bachelors degree or equivalent in a technical discipline or experience of such kind and amount as to provide a comparable background.
• 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 Inc. quality system, associated documentation, and product lines preferred or demonstrated medical device (or similar industry) quality system.

• 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.
• Frequently required to sit for extended periods, stand, walk, use hands to grasp, carry, feel or touch, reach with hands and arm, communicate.
• Utilizing close visual acuity for working with computers and equipment.