Job Description
Job Overview:
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 I / II Days (8am to 5pm)
LOCATION: Onsite at LSI Solutions in Victor, NY
SALARY RANGE: $72,000 - $106,000
JOB SUMMARY: 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.
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: problem statement development, root-cause investigation, corrective action development, implementation, and verification of effectiveness plan development.
- Prepare reports by collecting, analyzing, and summarizing data; makes recommendations for improvement for projects and CAPAs.
- Maintain, monitor, and present metrics about the CAPA, Gap Assessments, and Project system to management.
- Provide status and escalation information to management to maintain project schedules.
- Provide support for external audits and inspections as needed.
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.
Senior Quality Assurance Engineer
- All essential functions performed as part of Quality Assurance Engineers I & II.
- Act as a team lead for Quality Engineers or subject matter expert in a critical field of the Quality Management System (QMS).
- Identify areas for improvement within the QMS and lead/implement activities for improvement.
- Host external audits and inspections as needed.
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
- Minimum of 2-4 years of experience in problem solving, leading teams, and managing deliverables.
- Bachelor’s degree (Engineering, Business or a related field preferred) or equivalent experience.
- CAPA system experience preferred or leading problem-solving teams.
Quality Assurance Engineer II
- Minimum 2-4 years of experience in Quality Engineering required (preferably in medical device, automotive, aerospace or other regulated industry).
- Bachelor’s degree in technical discipline or equivalent experience.
- ASQ Certified Quality Engineer preferred.
Senior Quality Assurance Engineer
- Minimum 5-7 years of experience in Quality Engineering required (preferably in medical device, automotive, aerospace or other regulated industry).
- Bachelor’s degree in technical discipline required or equivalent experience.
- ASQ Certified Quality Engineer preferred.
KNOWLEDGE, SKILLS & ABILITIES:
- Excellent communication skills (verbal and written).
- Excellent computer skills (e.g. Microsoft Word, Excel, PowerPoint).
- 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.
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.
