Quality Engineering Supervisor

Job description

Job Summary We are seeking a dedicated and experienced Quality Engineering Supervisor to drive and maintain the highest standards of product quality and regulatory compliance within our medical device manufacturing operations. This role is critical for ensuring adherence to FDA regulations and ISO standards, encompassing responsibilities from design control and supplier management to advanced statistical analysis and quality auditing. The ideal candidate will leverage their expertise to proactively identify and mitigate quality risks, contribute to continuous improvement, and uphold our commitment to excellence in a highly regulated environment. Responsibilities: - Monitor and test the quality of products and processes in manufacturing environments, ensuring compliance with established standards and specifications. - Ensure adherence to GMP (21 CFR 820) and ISO 13485 quality system requirements throughout all quality engineering activities. - Respond to day-to-day production and customer quality issues related to production lines, resolving problems associated with process errors and non-conforming parts. - Facilitate and promote the use of appropriate problem-solving techniques fo...