Description

You own the execution and maintenance of quality systems within a regulated environment.

Responsibilities

• Develop and maintain quality system processes, including metrics reporting and tracking.
• Manage CAPA initiation, review, surveillance, and reporting cycles.
• Facilitate site Quality Management reviews and lead the site Change Management process.
• Support and lead root cause analyses through cross-functional team involvement.
• Coordinate and provide direct support for internal and external facility audits.

Required Skills

• 5+ years of Quality Assurance experience in a cGMP compliant environment (medical devices preferred).
• Proficiency with Quality Assurance, CAPA, and cGMP principles.
• Demonstrated ability to utilize statistics at a moderate level for trending and data interpretation.
• Effective communication, coaching, and presenting skills.
• Project management capabilities to deliver on time results.
• Technical writing proficiency.
• Competency in Microsoft Office tools, especially Excel, Word, and PowerPoint.
• Ability to manage change and make independent, sound decisions.

Preferred Skills

• Experience with MiniTab or equivalent statistical analysis software.

Key Skills

Education

Bachelor's degree