Bachelor's degree in a relevant science/technology field preferred.
5+ years Quality Assurance experience in a cGMP environment, medical devices preferred.
Strong communication and presentation skills.
Ability to manage change effectively.
Self-motivated with independent decision-making capabilities.
Proven project management abilities.
Demonstrated leadership and Emotional Intelligence.
Responsibilities
Develop and maintain quality system processes and metrics tracking.
Manage CAPA initiation, review, and reporting.
Facilitate site Quality Management Reviews and Change Management processes.
Lead root cause analyses with cross-functional teams.
Provide training on Good Documentation Practices and quality coordination on the floor.
Support facility audits and manage data for product recalls.
Perform trending of Quality Systems to assist FDA and Management reviews.
Benefits
Opportunity to lead quality culture initiatives.
Collaborative environment with Regulatory Affairs and Operations.
Focus on personal and professional development with training.
Engagement in cross-functional teamwork.
Direct involvement with site-wide initiatives for quality improvement.
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.
Ability to manage change.
Self-motivated with independent and sound decision-making capabilities.
Project management skills to deliver on-time results.
Leadership skills / Emotional Intelligence.
Ability to utilize statistics at a moderate level for trending and interpretation of statistical data.
