pawtucket, RI30+ days ago
Lead product complaint investigations, driving completion from receipt to resolution• Complete health risk assessments from product complaints or internal product/process/system issues• Develop and implement quality improvement programs• Support planning, review and approval of manufacturing process validations• Participate in change control activities for documents, manufacturing and QA/QC • Provide technical guidance to QA and QC personnel• Represent quality interests and concerns on project teams• Support manufacturing, new product development, and regulatory to ensure systems are compliant with all internal and external requirements• Collect, analyze and disseminate quality data throughout the organization• Participate in Material Review Board activities, including resolution of product nonconformities • Adhere to and ensure compliance with Quality System SOPs, work instructions, drawings, Good Manufacturing Practices (GMP), ISO, and FDA requirements• Participate in Risk Management activities• Monitor production quality performance to identify opportunities for improvements • Engage and interface in internal and external audits providing subject matter expertise.• Familiar with Statistical Analysis• Experience with ISO 13485, ISO 14971 and FDA QSR for Medical Devices• Possess strong organizational skills with the ability to manage and prioritize multiple tasks and meet deadlines• ASQ Certified Quality Engineer desirableKnowledge, Skills and AbilitiesUnderstands and has applied in practice the concepts of process capability, process control, and measurement system capability.