Hiring: Site Head of Quality Company: Trinity Biotech Location: Jamestown, NY Job Posted Time: 2026-09-10 10:57:13 Employment Type: Full-time / On-site Target Skills & Keywords : Quality Assurance, R, Regulatory Compliance, Root Cause Analysis, Six Sigma About the job Experience: •5+ years of experience in a quality management role, preferably within the medical device industry. Required Skills: •Acts as Management Representative and Person Responsible for Regulatory Compliance (PRRC) •Develop, implement, and manage the Quality Management System (QMS) in accordance with ISO 13485, FDA 21 CFR Part 820, and other relevant regulations and standards. •Lead and manage the Quality Assurance team, providing guidance, training, and performance evaluations. •Effectively manage external suppliers and distributors. •Establish quality objectives and key performance indicators (KPIs) to monitor and improve product and process quality. •Oversee internal and external audit programs, ensuring compliance with regulatory requirements and driving corrective and preventive actions (CAPA). •Partner cross-functionally with cross-functional teams, including R&D, manufacturing, and regulatory affairs, to ensure quality considerations are integrated into all stages of product development and production. •Drive continuous improvement initiatives using quality tools and methodologies such as Six Sigma, Lean, and root cause analysis. Qualifications: •Bachelor’s degree in Quality Assurance, Engineering, Life Sciences, or a related field. •In-depth knowledge of QMS standards and regulatory requirements, including ISO 13485 and FDA 21 CFR Part 820. •Proven leadership and team management skills. •Strong analytical and problem-solving abilities with experience in root cause analysis and CAPA. •Proficiency in statistical analysis tools and software (e.g., Minitab) •Excellent verbal and written communication skills. •Strong organizational skills and attention to detail. •Certification in quality management (e.g., ASQ Certified Quality Manager, Six Sigma) is a plus. Compensation: •$95,000 - $120,000 / year Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!