What are the responsibilities and job description for the Specialist, Quality Systems Analyst position at Cook Group?
Overview
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.
Responsibilities
This position supports quality system activities through data tracking, documentation, and coordination of audits, investigations, and continuous improvement efforts.
• Plan, document, and actively participate in external audits conducted by third parties, including regulatory authorities and certification bodies.• Compile, analyze, and distribute reports related to compliance, quality performance, business metrics, and customer complaints.• Assist in the preparation, tracking, and execution of quality planning activities.• Ensure that issues requiring corrective action are promptly identified, verified for successful implementation, and assessed for effectiveness. Integrate these actions into the Corrective and Preventive Action (CAPA) system as necessary.
• Conduct thorough investigations into product complaints, and ensure corrective actions are taken in line with company standards.
• Manage investigations related to out-of-tolerance calibrated equipment, ensuring that any issues are promptly addressed and documented for compliance purposes.• Participate in quality review boards and management review meetings.• Support and monitor ongoing process improvements, working closely with teams to drive initiatives that enhance product quality, efficiency, and compliance.
• Oversee the administration of the Cook Learn program, ensuring proper training, tracking, and documentation to meet organizational and regulatory standards.
• Maintain all training requirements for the position while actively seeking opportunities for continuous personal and professional development to stay updated with industry best practices.
• Adhere to the Quality Management System (QMS) and associated processes to ensure compliance with FDA 21 CFR 820, ISO 13485, and other relevant regulatory requirements.
Qualifications
• 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.
