Qualifications

• 6+ years of experience in Manufacturing Quality, Supplier Quality, Process Quality, or Validation.
• Experience in CAPA, client interactions, audits, and process quality activities.
• Familiarity with validation activities and quality system documentation.
• Proven ability to work in regulated manufacturing environments.
• Background in medical device manufacturing, particularly respiratory or sleep therapy products.
• Experience in supporting production transfers and validation execution.

Responsibilities

• Support manufacturing quality systems and daily quality assurance activities.
• Assist in executing validation protocols, production builds, and process verifications.
• Participate in PFMEA updates, process monitoring, and quality documentation.
• Assist with CAPA, tracking quality notifications, and corrective actions.
• Support supplier quality and engineering teams during transfer processes.
• Perform data collection and analysis for validation and quality activities.
• Engage in manufacturing audits and continuous improvement initiatives.

Benefits

• Opportunity to work in a dynamic, regulated environment.
• Collaboration with cross-functional teams to enhance manufacturing processes.
• Involvement in continuous improvement initiatives and compliance activities.
• Exposure to advanced quality systems and methodologies in the medical device sector.