Manufacturing Quality Engineer

About the role

The Manufacturing Quality Engineer will oversee calibration and preventive maintenance to ensure all equipment is suitable for use. They will also assist with documentation reviews, perform basic quality inspections, and enforce a strong quality culture.

Responsibilities

• Manage calibration and preventive maintenance
• Own calibration and preventive maintenance logs
• Schedule calibration and preventive maintenance activities while minimizing production downtime
• Maintain calibration and preventive maintenance records
• Aid with documentation reviews
• Review and approve basic nonconforming material reports
• Review Device History Records (DHRs) to ensure compliance
• Perform basic quality inspections
• Conduct or approve receiving activities to verify purchased product meets requirements
• Conduct basic quality inspections on the production line
• Manage process validation
• Perform installation qualification, operational qualification, and process qualification activities
• Ensure team members are aware of GMP principles
• Identify and correct GMP lapses when necessary

Requirements

• 3–8 years of experience in a medical device environment
• Comfortable with key medical device standards and regulations, including ISO 13485, 21 CFR 820, and ISO 14971
• Confident speaking up when identifying nonconformances or quality concerns
• Organized, detail-oriented, and comfortable working in a fast-paced manufacturing environment
• Excited to work hands-on and help build scalable quality systems at an early-stage company

Qualifications

• An engineering degree or equivalent experience
• Mechanical aptitude

Skills

• Experience with FDA inspections or MDSAP audits

Benefits

• Compensation Range: $95K - $130K

Pay

• $95K - $130K

Schedule

• N/A