Quality Engineer

Katalyst CRO; Madison (WI); On-site; USD 90,000 - 120,000; Full time

Job summary

Katalyst CRO in Madison, Wisconsin seeks a Senior Quality Analyst/Engineer to ensure CAPA, Change Management, investigations, deviations, QMR, audit coordination, and metrics are effectively managed for the Madison facility.

You will support Quality System improvements, data maintenance, trending, internal and external audits, and collaborate with Regulatory Affairs, Operations, Engineering, and Materials Management to drive a strong quality culture.

Qualifications

• Bachelor's degree or higher in science/technology preferred.
• 5+ years of Quality Assurance experience in a cGMP/regulated environment.
• Strong communication, coaching, and presentation skills; leadership abilities.

Responsibilities

• Develop and maintain quality system processes including metrics reporting.
• Manage CAPA initiation, review, surveillance, and reporting.
• Lead site Quality Management Reviews and Change Management processes.
• Support root cause analyses through cross-functional teams.
• Perform trending of Quality Systems for FDA and management reviews.
• Coordinate facility audits and support regulatory compliance.
• Lead training on Good Documentation Practice and QA on the floor.
• Utilize Minitab or equivalent for statistical data interpretation.

Skills

Effective communication

Coaching/mentoring

Presentation skills

Leadership

Emotional intelligence

Project management

Statistical analysis

Education

Bachelor's degree or higher in science/technology

Tools

Microsoft Office

Minitab

Job description

• 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.
• 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.

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.