The Medical Device Quality Assurance Specialist 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 RCA’s 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:
• Perform internal and external audits of systems and suppliers
• Filing and management of documentation when required
• Supporting other Quality System Functions
• This role may be required to lead personnel (inside and outside) the Quality organization in support of the business need
Minimum Requirements
• Bachelor’s, or higher, degree in science/technology program preferred
• 5+ years of experience in a cGMP Quality Assurance/Compliant environment (medical devices preferred)
• Effective communication, coaching/mentoring, and presenting skills
• Ability to manage change
• Self-motivated
• Independent and sound decision making capabilities
• Project management to deliver on time results
• Leadership skills / Emotional Intelligence
• Ability to utilize statistics at a moderate level for trending and interpretation of statistical data
Competencies:
• Proficient with Microsoft Office tools, especially Excel, Word and Powerpoint
• Technical writing
• Statistical analysis – Minitab or other software equivalent, preferred.
Organizational Relationship/Scope:
The Senior Quality Analyst collaborates closely with Manufacturing, Quality Control, Engineering, Facilities, Materials Management, Regulatory Affairs, and Process Development. The individual must be able to perform in a fast-paced environment with strict adherence to timelines. The position is onsite during normal working hours M-F, but may be required to work extra hours or on weekends or holidays in order to support business needs.
Working Conditions:
The Senior Quality Analyst will mainly work in an office environment. Domestic and international travel will be required on a limited basis.
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