Overview:
Job Title: Senior Quality Analyst/Engineer
Job Type: Contract
Job Location: Madison, WI
Summary
The Senior Quality Analyst/Engineer 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
โข Develop and maintain quality system processes, including metrics reporting and tracking
โข Manage CAPA initiation, review, surveillance, and reporting
โข Facilitate the site Quality Management reviews
โข Facilitate and lead the site Change Management process
โข Support and lead root cause analyses through cross functional team involvement
โข Leading Good Documentation Practice training and Quality on the Floor coordination and performance
โข Interpret and properly apply all applicable regulatory requirements
โข Coordinate and provide direct support for facility audits by internal and external entities
โข Manage data collection and reporting when product recalls are required
โข Perform trending of Quality Systems to support FDA and Management reviews
โข Improve quality culture through site initiatives and improve existing procedures to better align with regulatory requirements
โข Review and approval of procedures, protocols, reports, etc., as required.
Department specific/Non-essential responsibilities:
โข Filing and management of documentation when required
โข Supporting other Quality System Functions
โข This role may be required to lead personnel (inside and outside) the Quality organization in support of the business need
Minimum Requirements
Experience / Skills:
โข Bachelor's, or higher, degree in science/technology program preferred
โข 5+ years of Quality Assurance experience in a cGMP Quality Assurance/Compliant environment (medical devices preferred)
โข Effective communication, coaching/mentoring, and presenting skills
โข Ability to manage change
โข Self-motivated
โข Independent and sound decision making capabilities
โข Project management to deliver on time results
โข Leadership skills / Emotional Intelligence
โข Ability to utilize statistics at a moderate level for trending and interpretation of statistical data
Competencies:
โข Proficient with Microsoft Office tools, especially Excel, Word and Powerpoint
โข Technical writing
โข 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.
Skills:
CAPA,CGMP,QUALITY ASSURANCE