Quality Engineer I II Finished Goods Onsite (Days 8am to 5pm)

About the Role

LSI SOLUTIONS® is a dynamic and growing medical device company with over 500 employees dedicated to advancing minimally invasive surgical instruments. 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 an energetic team working together to relentlessly pursue better patient outcomes with state-of-the-art devices. After all, our customer is ultimately the patient.

Shift: 8:00am to 5:00pm
Location: Onsite at LSI Solutions in Victor, NY

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 Focus

• 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 LSI's 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 Responsibilities

• 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

• 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 Process Control Plans (PCP)
• Geometric Dimensioning & Tolerancing (GD&T) Fundamentals
• Familiarity with Gauge Repeatability and Reproducibility (R&R) for gauging and fixturing
• Strong proficiency in MS Word, Excel, and Outlook
• Strong written and verbal communication skills

Finished Goods Additional KSAs

• Experience in documenting and reviewing risk assessments
• Experience in terminal sterilization
• Experience in cleanroom environmental monitoring
• A strong working knowledge of ISO 11135 and/or ISO 14644
• Experience in technical transfer of product to manufacturing preferred

Physical Demands and Work Environment

• Frequently required to lift, carry, push and/or pull from 10-20 lbs
• Ability to periodically bend or kneel and use color vision/depth perception
• Sitting, standing and/or walking for up to eight (8) hours per day
• Routine use of standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines
• Regularly required to talk and/or hear
• Ability to travel to suppliers on average 25% to support responsibilities defined above (for external Supplier function only)

Benefits

• Bonus Plan
• 401(k) plan with company match
• Tuition Assistance
• Employee Assistance Program (EAP)
• Product Discounts
• 15 Paid Holidays, PTO, Sick Time
• Medical, Vision and Dental effective first day of employment