Quality Engineer I or II Finished Goods

**LSI SOLUTIONS® founded in 1986, located in beautiful Victor, New York, is a dynamic and growing medical device company with over 500 employees dedicated to advancing minimally invasive surgical instruments through research, development, manufacturing, and marketing. We have doubled in size in just the last 4 years! The LSI Campus includes 10 buildings (170,000+ sq ft) on 95 meticulously cared for acres.** **We are searching for passionate people looking to make a difference in the medical device industry. By joining LSI SOLUTIONS® an ISO 13485 certified company, you will become part of as energetic team working together to relentlessly pursue better patient outcomes with state-of-the-art devices. After all, our customer is ultimately the patient.** **POSITION TITLE: Quality Engineer I or II Finished Goods** **SHIFT HOURS: 8:00am to 5:00pm (days)** **LOCATION: Onsite at LSI Solutions in Victor, NY** **SALARY PAY RANGE:** **$75,000yr to 95,000yr** **JOB SUMMARY:** Perform quality engineering tasks for new & existing product and process development and improvement initiatives. Quality Engineers are specialized in either Supplier Quality Engineering, Design Quality Engineering, Metrology Quality Engineering or Finished Goods Quality Engineering. Quality Engineers interface with other functions within an organization and with internal and external customers and suppliers on quality-related issues. **ESSENTIAL FUNCTIONS:** **Quality Engineer I:** - Assist in the development of Quality Management System (QMS) processes and procedures to ensure compliance with applicable regulations. - Coordinate and disposition non-conforming product. - Perform data analysis, and develop, monitor, and oversee metrics reporting. - Lead and/or support continuous improvement activities. - Support and participate in internal and external audits and inspections. - Generate and maintain procedures, work instructions, inspection plans, forms, and templates. - Lead and/or participate on Corrective Action and Preventive Action (CAPA) investigations. - Review/approve verification & validation protocols and reports. **Quality Engineer II:** - Demonstrate knowledge in the Quality Engineering functions listed above, plus: - Lead Activities for the development of the QMS. - Responsibility and ownership for product line and/or process Quality Engineering deliverables. - Lead continuous improvement activities. - Lead Corrective Action and Preventive Action (CAPA) investigations. - Work independently as a self-starter with minimal direction. **Finished Goods:** - Conduct finished goods health risk assessments. - Maintain sterilization validations, and act as sterilization subject matter expert for new product development. - Maintain and improve environmental monitoring program. - Develop and maintain process monitoring of Finished Goods team QMS processes. - Develop and maintain product/process monitoring of LSIs finished goods products and processes. - Analyze product and process monitoring data to identify opportunities for improvement. Coordinate improvements in finished goods work centers. - Provide input to the maintenance of pFMEA, PFD, control plans. **ADDITIONAL RESPONSIBLITIES:** - All other duties as assigned. **EDUCATION & EXPERIENCE:** **Quality Engineer I:** - Bachelor’s degree or higher in a technical discipline required. - 0-3 years of relevant Engineering experience in medical device or other regulated industry preferred. **Quality Engineer II:** - Bachelor’s degree or higher in a technical discipline with 3 or more years of relevant experience in medical device or other regulated industry required. **KNOWLEDGE, SKILLS & ABILITIES:** The following KSAs apply to all Quality Engineers: - Knowledge and application of ISO 13485. - Strong problem solving, root cause analysis and analytics skills. - Familiarity with quality engineering concepts and tools, e.g. Statistical Process Control (SPC), Capability Analyses, Design of Experiments (DOE’s), and Proc…