Job Title Sr. Quality Engineer Department Operations Reports to Sr. V.P. of Operations FLSA Status Exempt PURPOSE OF POSITION Support new product development, spearhead product & process investigations & improvements and optimize supplier relationships. MAJOR DUTIES AND RESPONSIBILITIES Product Development Provide guidance on ISO & QSR requirements as part of the QA support to new product developments, lead Risk Management effo1is in accordance with ISO 14971, and lead process qualification and validation efforts, including IQOQPQ protocols and reports. Product Quality -Provide leadership in the improvement of product quality through proactive means as well as complaint analysis, investigation and corrective action. Quality Systems Support the ISO, EN, and MDD certification process and compliance to FDA regulations by assisting in the development, implementation, monitoring, and improvement of quality systems. Supplier Quality -Responsible, along with the Supply Chain Manager and Quality Manager, for maintaining supplier relationships and providing supplier qualifications and audits. Work with suppliers to respond to any SCARs and to facilitate corrective actions to Non conformances.