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. JOB TITLE: Quality Technician I, II, Sr. HOURLY PAY RANGE: $24.00/hr - $34.00/hr. POSITION HOURS: Days 7:00AM to 3:30PM LOCATION: Onsite at LSI Solutions in Victor, NY JOB SUMMARY: The Quality Technician Level I, II, and Sr. are responsible for assessments, inspections, line clearances, and documentation review of vendor related and in house manufactured components and product. Collect data and apply basic statistical quality tools. Demonstrate documentation skills required of a medical device company. The Quality Technician Level II also participates in a team setting to investigate and problem solve. The Sr. Quality Technician Level is a technical SME and or Team Lead who trains, coaches and assists in New Product Development and supports planning of near term work load for the team. ESSENTIAL FUNCTIONS: Quality Technician I + Inspection and In-process audit of material status throughout product realization. + Ensure enforcement of good documentation practices within Device History Records. + Perform Lot Inspections (incoming and final product). + Segregate and control Non-Conforming Material. + Assist Quality Engineering with testing in support of root cause analysis and verification/validation activities. + Perform basic statistical analysis in support of investigations. + Assist in internal audits as required. + Support the existing quality systems and regulatory functions. + Proficient with basic measurement tools and understand their limitations. + Establish work prioritization for quality work areas and assign tasks accordingly. + Ability to read and interpret GD&T. + Assist with the creation and editing of work instructions. Quality Technician II All level I functions, plus the following: + Populate and maintain database for metrics reporting. + Coordinate nonconformance reports. + Intermediate GD&T knowledge. + Assist with training and coaching. + Suggest process and system improvements. + Create & update procedures and work instructions. + Subject matter expert in one or more of the following: + Programming one or more complex measurement systems type + Product flow and support through quality system processes + Statistics Senior Quality Technician All level II functions, plus the following: + Assist Supervisor in the prioritization of activities. + Mentor and provide guidance to other Technicians & Inspectors. + Participate in New Product Development (NPD) print review. + Advanced knowledge in statistics. + Subject matter expert in three or more of the following: + Programming two or more complex measurement systems type + Advanced GD&T knowledge + Design & development of gages & fixtures + Gage Repeatability and Reproducibility ADDITIONAL RESPONSIBILITIES : + All other duties as assigned. EDUCATION & EXPERIENCE: Quality Technician I Any of the following exhibit acceptable experience for this position: + High School Diploma or GED & 3 years’ experience in quality field. + Certified Quality Technician (CQT) or Associates degree in a technical discipline plus 1 year of related experience. + CMM and Vision System program experience preferred. Quality Technician II Any of the following exhibit acceptable experience for this position: + 6 years’ experience in quality field or 3 years’ quality experience in medical manufacturing. + Certified Quality Technician (CQT) or Associates degree in a technical discipline plus 3 year of related experience. Senior Quality Technician Any of the following exhibit acceptable experience for this position: + 12 years’ experience in quality field or 7 years’ quality experience in medical manufacturing. + Certified Quality Technician (CQT) or Associates degree in a technical discipline plus 7 year of related experience. + Bachelor’s degree in a technical discipline plus 5 years’ experience in quality field in a regulated industry. KNOWLEDGE, SKILLS & ABILITIES: + Good communication skills (both verbal and written). + Team Player. + Understanding of quality concepts and tools. + Understanding of basic statistics. + Understanding of process control methods. + Able to read engineering drawings (GD&T knowledge a plus). + Understand acceptance sampling concepts and able to use ANSI/ASQ Z1.4. + Experience in an ISO 9000 environment a plus. + Medical Device experience a plus. + Internal auditing experience a plus. + Familiarity with automated vision systems and coordinate measuring machines. PHYSICAL DEMANDS AND WORK ENVIRONMENT: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. I can, with or without reasonable accommodation(s), perform the essential functions of this position: + Sitting, standing and/or walking for up to eight hours per day. + Frequently required to lift and/or carry up to 30 lbs. + Occasionally required to push/pull up to 100+ lbs. – full pallets with pallet jack + Occasionally required to climb, reach, and perform repetitive motion. + Regularly required to climb, stoop, kneel, crouch, crawl, and handle. + Regularly required to talk and/or hear, see, see color, and depth perception. LSI SOLUTIONS® is an equal opportunity employer and does not discriminate based on any legally protected status or characteristic. Minority/Female/Sexual Orientation/Gender Identity/Disability/Veteran.