Quality Engineer II

Laborie Medical Technologies Corp • Orangeburg, NY

23h • Onsite

About The Position

As a key member of our Quality team, the Quality Engineer II will play a crucial role in providing support to our Orangeburg NY location. The primary focus for the Quality Engineer II will be to lead quality assurance initiatives, ensuring that processes, products, and systems comply with regulatory and company standards. The Quality Engineer II serves as a technical resource for cross-functional teams.

Requirements

• Bachelor's degree in an Engineering discipline with minimum 5 years' experience in Quality Engineering
• Medical device or regulated industry experience required
• Experience with Risk Management (ISO 14971 preferred)
• Experience with quality audits (lead auditor certification preferred)
• Strong attention to detail and organizational skills with demonstrated ability to lead projects and work independently

Nice To Haves

• ASQ certification and Lean Six Sigma training preferred

Responsibilities

• Perform quality activities in support of Operations, R&D and contract manufacturers.
• Support design and engineering change processes and associated documentation and internal and external audit activities and work to resolve audit nonconformities.
• Perform quality activities related to CAPA process.
• Represent Quality Engineering in the development and maintenance of process and product risk assessments (i.e., FMEAs).
• Participate in Material Review Board reviews including material segregation, investigation, corrections, and dispositions.

Benefits

• Paid time off
• paid volunteer time
• Medical, Dental, Vision and Flexible Spending Account
• Health Savings Account with Company Funded Contributions
• 401k Retirement Plan with Company Match
• Parental Leave and Adoption Services
• Health and Wellness Programs and Events

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 251-500 employees