Senior Quality Assurance Analyst (Medical devices) - Madison, WI

Senior Quality Assurance Analyst (Medical devices) - Madison, WI

Senior Quality Assurance Analyst (Medical devices) - Madison, WI

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Senior Quality Assurance Analyst (Medical devices)

Location : Madison, WI

Duration : 6+ months contract

Pay Rate : $42 / hr

Primary duties for this position - Develop / maintain quality system processes, metrics calculations / tracking / trending, coordinate internal / external audits, front room support during audits, coordinate / perform quality inspections on the floor, lead good documentation practice training

The Quality Analyst is responsible for assuring that activities, processes, and product related to managing the processes of CAPA, Change Management, investigations, deviations, Quality Management Review, Audit coordination, and metrics for the Madison facility. This position will have a wide range of tasks which may include Quality System improvement initiatives, data maintenance, trending and reporting, deviation investigation, internal / external auditing, and direct involvement and collaboration with the Regulatory Affairs, Operations, Technical Operations, Engineering, and Materials Management groups to drive quality culture.

Principal Responsibilities

• Develop and maintain quality system processes
• Manage CAPA initiation, review, surveillance, and reporting
• Facilitate the site Quality Management reviews
• Facilitate and lead the site Change Management process
• Coordinate facility audits by internal and external entities
• Manage data collection and reporting when product recalls are required
• Support and lead RCAs through cross functional team involvement
• Perform trending of Quality Systems to support FDA and Management reviews
• Coaching and mentoring others in regards to QMS and Quality Culture, including leading Good Documentation Practice training and Quality on the Floor coordination and performance
• Improve existing procedures to align with cGMP and regulatory requirements
• Interpret and properly apply all applicable regulatory requirements
• Improve quality culture through site initiatives
• Review and approval of procedures, protocols, reports, etc., as required.

Department Specific / Non-essential Responsibilities

Minimum Requirements

Experience / Skills :

Seniority level

Seniority level

Associate

Employment type

Employment type

Full-time

Job function

Job function

Quality Assurance

Industries

Medical Equipment Manufacturing and Pharmaceutical Manufacturing

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