Quality Manager - Manufacturing

Job Overview We are seeking an experienced and detail-oriented Quality Manager to oversee manufacturing quality systems and build a strong quality culture. The ideal candidate will lead quality assurance initiatives, work collaboratively with manufacturing operations, conduct audits, and implement continuous improvement strategies to maintain the highest standards of product quality. This role is vital in supporting manufacturing operations, ensuring regulatory compliance, and fostering a culture of quality excellence across the organization. Duties Develop, implement, and maintain quality management systems aligned with

ISO 13485, ISO 9001, FDA

regulations, CGMP, and other relevant standards. Train and Lead Quality Staff. Lead internal and external quality audits to verify compliance with regulatory requirements and company policies. Oversee quality control processes including inspections, testing, and validation activities to ensure product integrity. Collaborate with manufacturing teams to identify root causes of quality issues and develop corrective and preventive actions (CAPA). Manage documentation related to quality procedures, audit reports, non-conformance reports, and regulatory submissions. Facilitate training programs for staff on quality systems, standards, and best practices. Monitor key performance indicators (KPIs) related to quality metrics and drive continuous improvement initiatives. Ensure compliance with FDA regulations, ISO standards, and other applicable industry requirements. Coordinate project management efforts for new product launches or process improvements related to quality assurance. Analyze data trends to identify areas for process optimization and risk mitigation. Qualifications Proven experience in manufacturing quality leadership. Strong knowledge of

ISO 13485, ISO 9001, FDA

regulations, CGMP standards. Strong ability to work cooperatively with operations and manufacturing staff. Demonstrated expertise in conducting quality audits and inspections. Proficiency in developing and managing quality systems (QA/QC), documentation control, and compliance protocols. Excellent project management skills with the ability to lead cross-functional teams. Strong analytical skills with the ability to interpret complex data sets for decision-making purposes. Effective communication skills for training staff and liaising with regulatory agencies.

Pay:

$66,000.00 - $71,000.00 per year

Benefits:

401(k) 401(k) matching Dental insurance Health insurance Health savings account Life insurance Paid time off Vision insurance

Work Location:

In person