Quality Engineer

Responsibilities

• Manage and resolve quality issues including nonconformances, CAPAs, and deviations
• Facilitate customer-focused meetings to address quality and performance concerns
• Provide technical support for validation activities and ensure compliance with regulatory standards
• Lead discussions on Good Manufacturing Practices (GMP) and drive process improvement initiatives
• Oversee risk management activities to mitigate potential quality and compliance risks
• Develop and implement methods for inspection, testing, and evaluation of products and equipment
• Design sampling procedures and develop instructions for recording and reporting quality data
• Compile training materials and conduct sessions on quality control activities
• Approve product, process, and equipment qualifications

Requirements

• Bachelor's degree in a related field or equivalent experience
• 4 years of quality engineering experience
• 2 years of medical device experience and knowledge of ISO13485
• Previous manufacturing experience
• Proficiency with FMEAs, CAPA, Root Cause Analysis, and Lean Six Sigma tools

Benefits

• Full range of medical, dental, and vision plans
• Life Insurance
• Short-term and Long-term Disability
• Matching 401(k) contributions
• Vacation and paid sick time
• Tuition reimbursement

About the Company

Flex is the diversified manufacturing partner of choice that helps market-leading brands design, build, and deliver innovative products that improve the world. We offer the opportunity to make a difference and invest in your growth in a respectful, inclusive, and collaborative environment.