Quality Assurance Engineer I or II Onsite (Days 8am to 5pm)
About The Position
LSI SOLUTIONS®, founded in 1986 and located in Victor, New York, is a growing medical device company with over 500 employees focused on advancing minimally invasive surgical instruments. As an ISO 13485 certified company, LSI SOLUTIONS® is seeking passionate individuals to join an energetic team dedicated to improving patient outcomes through state-of-the-art devices. The Quality Assurance Engineer will provide quality engineering support to ensure regulatory compliance and adherence to industry best practices through systems development, and will lead and support quality system continuous improvement initiatives.
Requirements
- Bachelor’s degree (Engineering or related field preferred)
- 0-3 years of experience in a regulated industry (for QA Engineer I)
- 3-7 successful years of experience in Quality Engineering required, with experience within the medical device industry preferred (for QA Engineer II)
- Demonstrated experience leading problem-solving and regulatory compliance driven efforts. (for QA Engineer II)
- Excellent communication skills (verbal and written).
- Excellent computer skills (e.g. Microsoft Word, Excel, PowerPoint).
- Customer-focused, goal-oriented self-starter.
- 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.
Nice To Haves
- ASQ Certified Quality Engineer preferred. (for QA Engineer II)
- Ability to facilitate and mentor a team.
- Ability to train employees at multiple levels of an organization.
Responsibilities
- 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.
- 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.
- Prepare reports by collecting, analyzing, and summarizing data; makes recommendations for improvement.
- All other duties as assigned.
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
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
