Quality Assurance Engineer

LSI Solutions Inc•Victor, NY

4d•Onsite

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. The company has doubled in size in the last 4 years and operates from a 170,000+ sq ft campus on 95 acres. LSI SOLUTIONS® is an ISO 13485 certified company seeking passionate individuals to contribute to the medical device industry and improve patient outcomes with 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)
7+ successful years of experience in Quality Engineering within the medical device industry required (for Senior QA Engineer)
Demonstrated experience leading effective problem-solving and regulatory compliance driven efforts including the development and maintenance of critical QMS processes (for Senior QA Engineer)
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 and Senior QA Engineer)
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.
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.
All other duties as assigned.