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About the Role

The Quality Assurance Engineer provides quality engineering support to ensure regulatory compliance and industry best practices through systems development. This role is responsible for leading and supporting quality system continuous improvement initiatives.

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.
• Perform all other duties as assigned.

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)
• Completion of a relevant degree not listed above may be considered with additional applicable experience.

Skills

• 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

Location

• Victor, NY

Work Type

• Onsite
• Full-time

Experience Level

• 0-3 years (QA Engineer I)
• 3-7 years (QA Engineer II)

Education Level

• Bachelor's degree (Engineering or related field preferred)
• ASQ Certified Quality Engineer preferred (for QA Engineer II)

Salary/Compensations

• $75,000 to $95,000

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

About the Company

• LSI SOLUTIONS® founded in 1986, 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.
• The company has doubled in size in the last 4 years and includes 10 buildings (170,000+ sq ft) on 95 acres.
• LSI SOLUTIONS® is an ISO 13485 certified company.
• The company is searching for passionate people looking to make a difference in the medical device industry.
• The team is energetic and works together to relentlessly pursue better patient outcomes with state-of-the-art devices, as the customer is ultimately the patient.

Equal Opportunity

• 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.