Bachelor's degree or higher in a science/technology program preferred
5+ years of Quality Assurance experience in a cGMP Quality Assurance/Compliant environment, preferably with medical devices
Effective communication, coaching/mentoring, and presentation skills
Ability to manage change
Self-motivated with independent decision-making capabilities
Project management skills for timely results
Strong leadership skills and emotional intelligence
Responsibilities
Develop and maintain quality system processes with metrics reporting
Manage CAPA initiation, review, and reporting
Facilitate site Quality Management Reviews
Lead the Change Management process on-site
Support root cause analyses with cross-functional teams
Conduct Good Documentation Practice training
Coordinate facility audits with internal and external entities
Perform Quality Systems trending for FDA and management reviews
Initiate site initiatives to improve quality culture
Benefits
Support for continuous education and professional development
Opportunities for cross-functional collaboration
Engagement in a quality-driven culture
Access to tools for data analysis and reporting
Leadership development and mentoring opportunities
Full Job Description
Job Summary:
The Senior Quality Analyst/Engineer is responsible for assuring that activities, processes, and products related to CAPA, Change Management, investigations, deviations, Quality Management Review, audit coordination, and metrics are effectively managed for the Madison facility.
The role will also support Quality System improvement initiatives, data maintenance, trending and reporting, deviation investigation, internal/external auditing, and collaboration with Regulatory Affairs, Operations, Technical Operations, Engineering, and Materials Management groups to drive quality culture.
Roles & Responsibilities:
Develop and maintain quality system processes, including metrics reporting and tracking.
Manage CAPA initiation, review, surveillance, and reporting.
Facilitate site Quality Management Reviews.
Facilitate and lead the site Change Management process.
Support and lead root cause analyses through cross-functional team involvement.
Lead Good Documentation Practice training and Quality on the Floor coordination and performance.
Interpret and properly apply all applicable regulatory requirements.
Coordinate and provide direct support for facility audits by internal and external entities.
Manage data collection and reporting when product recalls are required.
Perform trending of Quality Systems to support FDA and Management reviews.
Improve quality culture through site initiatives and improve existing procedures to better align with regulatory requirements.
Review and approve procedures, protocols, reports, etc., as required.
File and manage documentation when required.
Support other Quality System Functions.
Lead personnel, inside and outside the Quality organization, in support of business needs.
Utilize Microsoft Office tools, especially Excel, Word, and PowerPoint.
Perform technical writing.
Utilize statistical analysis, including Minitab or equivalent software, for trending and interpretation of statistical data.
Education & Experience:
Bachelor's degree or higher in a science/technology program preferred.
5+ years of Quality Assurance experience in a cGMP Quality Assurance/Compliant environment, with medical devices preferred.
Effective communication, coaching/mentoring, and presentation skills.
bility to manage change.
Self-motivated with independent and sound decision-making capabilities.
Project management skills to deliver on-time results.
Leadership skills / Emotional Intelligence.
bility to utilize statistics at a moderate level for trending and interpretation of statistical data.
