The Manager, Quality Assurance, is crucial in leading our dedicated QA team and ensuring every product achieves high standards, customer satisfaction, and regulatory standards. This role is unique by providing an opportunity to operate in a dynamic environment where your contributions have a direct impact on our success and reputation.

To perform this job successfully, an individual must be able to capably perform each of the following essential duties:

• Oversee, manage, coordinate, lead, and prioritize quality assurance (QA) activities to guarantee adherence to ISO 9001, customer, regulatory, and quality management system (QMS) standards.
• Lead and develop the QA team by defining priorities and arranging daily tasks. Deliver mentoring, training, and performance evaluation. Promote a culture of quality, ownership, conformity, and ongoing progress.
• Coordinate product inspection, batch release, and disposition activities to guarantee products meet established quality, customer, and regulatory standards.
• Coordinate quality system processes such as document control, record management, CAPA’s, deviations, non-conformances, change control, supplier quality, management review, and audits, acting as the site’s Management Representative.
• Direct the establishment, execution, and continual advancement of the QMS by following quality performance statistics and reviewing quality data trends. Coordinate CAPA effectiveness and support quality aims. Explore ways to improve conformity and operational results.
• Direct internal, customer, supplier, and regulatory audit processes, acting as the chief contact for auditors, regulatory authorities, customers, and suppliers; manage audit responses, regulatory inspections, and ensure the swift closure of audit findings, CAPA’s, deviations, and non-conformances.
• Review and approve quality documentation, specifications, protocols, validation packages, technical reports, and quality records to guarantee alignment with internal and external requirements.
• Monitor, examine, and share quality performance metrics and crucial compliance indicators, providing regular updates and recommendations via management review processes.
• Lead continuous advancement projects by reviewing quality metrics, risk analyses, audit findings, customer insights, and operational performance patterns.
• Work closely with Operations, Quality Control, Supply Chain, customers, suppliers, and regulatory bodies to advance business goals, ensure quality standards, and maintain regulatory adherence.
• Provide leadership and subject matter expertise on quality systems, regulatory requirements, auditing, and industry guidelines, maintaining knowledge of ISO 9001, ISO 13485, and applicable FDA regulations.
• Perform other duties as required to support quality, compliance, operational, and business objectives.