Quality Assurance Engineer (Medical Device)

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process. Quality Assurance Engineer (Medical Device) Full Time Victor, NY, Victor, NY, US 10 days ago Requisition ID: 2633 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 Assurance Engineer (Days 8am to 5pm) SHIFT HOURS: 8:00am to 5:00pm. LOCATION: Onsite at LSI Solutions in Victor, NY. SALARY RANGE: $77,000 to $110,000 The Quality Assurance Engineer provides quality engineering support to ensure regulatory compliance and industry best practices through systems development. Additionally, the Quality Assurance Engineer is responsible for leading and supporting quality system continuous improvement initiatives. REPORTS TO: Quality Assurance Manager

SUPERVISES: N/A

ESSENTIAL FUNCTIONS:

Quality Assurance Engineer I Ensure Quality Management System (QMS) processes conform with quality standards and comply with regulations. Perform gap assessments for external standards, regulations, and QMS documentation. Develop, write and revise QMS documentation, ensuring that process linkages are correctly documented throughout the QMS. Develop and update procedures, work instructions, and quality plans. Develop and track project timelines for CAPA, Gap Assessments, and Project activities Prepare reports by collecting, analyzing, and summarizing data; makes recommendations for improvement via suggestions for quality projects (Q projects) and CAPA requests. Maintain, monitor, and present metrics about the CAPA, Gap Assessments, and Q Projects to management. Provide status and escalation information to management to maintain project schedules. Provide support for external audits and inspections as needed. Assist with CAPA investigation, root cause analysis, solution plan implementation, and VOE execution Quality Assurance Engineer II All essential functions listed above performed as part of Quality Assurance Engineer I. Perform internal audits as needed. Assist in quality system continuous improvement initiatives. Teach and mentor Quality Assurance Engineers on quality system requirements, gap assessments and concepts. Proactively identify and collaborate with key project team members to maintain project schedules, escalating to management when necessary Own the execution of CAPA specific tasks such as root cause analysis, solution plan implementation, and VOE. Senior Quality Assurance Engineer All essential functions performed as part of Quality Engineers I & II. Act as a team lead for Quality Engineers or subject matter expert in a critical area of the Quality Management System (QMS). Identify areas for improvement within the QMS and lead/implement activities for improvement. QMS subject matter expert for external audits as needed. Lead CAPA investigations as required.

ADDITIONAL RESPONSIBILITIES :

Prepare reports by collecting, analyzing, and summarizing data; makes recommendations for improvement. All other duties as assigned.

EDUCATION & EXPERIENCE:

Quality Assurance Engineer I Bachelor’s degree (Engineering or related field preferred) 0-3 years of experience in a regulated industry Quality Assurance Engineer II Bachelor’s degree (Engineering or related field preferred) 3-7 successful years of experience in Quality Engineering required, with experience within the medical device industry preferred Demonstrated experience leading problem-solving and regulatory compliance driven efforts. ASQ Certified Quality Engineer preferred. Senior Quality Assurance Engineer Bachelor’s degree (Engineering or related field preferred) 7+ successful years of experience in Quality Engineering within the medical device industry required. Demonstrated experience leading effective problem-solving and regulatory compliance driven efforts including the development and maintenance of critical QMS processes. ASQ Certified Quality Engineer preferred. Completion of a relevant degree not listed above may be considered with additional applicable experience.

KNOWLEDGE, SKILLS & ABILITIES:

Excellent communication skills (verbal and written). Ability to facilitate and mentor a team. Customer-focused, goal-oriented self-starter. Ability to train employees at multiple levels of an organization. Strong problem solving and analytical skills. Familiarity with statistical tools such as SPC, CpK, DOEs, and FMA. Familiarity with basic LEAN concepts and tools, e.g. 5S, Kaizen, Value Stream Mapping.

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. Regularly required to sit; use hands to handle or feel and talk or hear. Frequently required to reach with hands and arms. Occasionally required to stand; walk and stoop, kneel, crouch. Occasionally lift and/or move up to 10 – 20 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

GENEROUS LSI BENEFITS INCLUDE:

Bonus Plan, 401(k) plan with company match, Tuition Assistance, Employee Assistance Program (EAP) and Product Discounts 15 Paid Holidays, PTO, Sick Time Medical, Vision and Dental effective first day of employment LSI SOLUTIONS® is an equal opportunity employer and does not discriminate on the basis of any legally protected status or characteristic. #J-18808-Ljbffr LSI SOLUTIONS, Inc.