Sr. Quality Systems Engineer - CAPA

Sr. Quality Systems Engineer - CAPA

Department: Quality

Employment Type: Full Time

Location: US-North Carolina-Raleigh

Description

As a Sr. Quality Systems Engineer- CAPA, you will be responsible for maintaining and executing the Invisalign Multi-Site Corrective and Preventive Action (CAPA) process to ensure compliance with regulatory requirements and improve product quality and processes. You will also assist with training, documentation and change control processes.

Role expectations

• Lead and manage the CAPA process, including investigation, root cause analysis, and implementation of corrective and preventive actions.
• Collaborate with cross-functional teams to identify and resolve quality issues.
• Develop and maintain CAPA documentation, ensuring accuracy and compliance with regulatory standards.
• Partner with global teams to provide an independent, technical review of CAPAs
• Monitor the effectiveness of CAPA actions and make necessary adjustments to ensure continuous improvement.
• Conduct regular CAPA reviews and audits to ensure compliance and effectiveness.
• Provide training and support to team members on CAPA processes and best practices.
• Prepare and present CAPA reports to management and regulatory bodies as required.
• Stay updated on industry regulations and standards related to CAPA and quality management.
• Report on status of CAPA system in alignment with site and corporate KPI's
• Support harmonization of QMS elements following Global initiatives and incorporation of systems.
• Lead and support ongoing Quality Improvement projects and initiatives.

What we're looking for

• Bachelor's degree required
• Quality professional with minimum 6 years of experience - advantage in medical device industry
• At least 4 years of direct CAPA experience, owning CAPAs, performing, root cause analysis using a variety of problem solving methodologies, and ideally performing CAPA training.
• Experience in medical device and knowledge in ISO13485 & 21 CFR Part 820
• Ability to organize information effectively, prioritizing tasks according to their urgency and importance.
• Ability to operate efficiently and effectively in a fast-paced environment
• Ability to work independently and lead end to end activities
• Strong written and verbal communication skills and teamwork skills
• Proficiency in Arena is an advantage
• Fluent in English, spoken and written