About the Role As a Quality Assurance Lead, you will spearhead our quality initiatives by overseeing inspection personnel and ensuring rigorous adherence to regulatory standards. You will play a pivotal role in optimizing production quality processes and serving as a key technical resource for the department. Responsibilities Direct and mentor quality inspection staff to ensure consistent performance and professional development. Enforce

ISO 13485

compliance across all production and laboratory activities to maintain high-quality output. Streamline quality procedures and documentation to improve operational efficiency and audit readiness. Coordinate with cross-functional teams to resolve complex quality issues and align on production priorities. Manage shift staffing and training schedules to ensure seamless coverage and skill competency. Utilize SPC software to monitor process stability and drive continuous improvement initiatives. Act as a primary point of contact for quality-related inquiries and provide leadership support to the QA management team. Required Skills High school diploma or equivalent required; Associate or Bachelor degree preferred. Minimum of 2 years of experience supervising a QA lab within an

ISO 13485

regulated environment. Demonstrated proficiency in MS Office Suite (Excel, Word, PowerPoint, Outlook). Strong technical aptitude with Statistical Process Control (SPC) software. Exceptional organizational and communication skills to facilitate knowledge sharing. Ability to pass pre-employment reading and measurement assessments. Preferred Skills Prior experience within the flexible packaging industry. Hands-on experience with ERP systems for data management. Proven track record of managing quality workflows in a medical device or pharmaceutical setting.