Quality Engineer

MTS is a contract manufacturer of medical devices and is seeking a Quality Engineer. The Quality Engineer will work with the Quality Team and ensure quality of manufactured product from product launch to distribution. This person will evaluate current manufacturing processes; to include management of suppliers as well as incoming, in-process and final inspection activities and identifying areas for continuous improvement. The role shall also be responsible for calibration and maintenance of gauges, tools and equipment.

Other Key Responsibilities include:

• Assist Project Manufacturing Engineering with PFMEAs and Control Plans and other PPAP deliverables as a part of product launch
• Manage, record and/or conduct first article inspections as a part of product launch
• Evaluate and document supplier evaluations and approvals as well as continuous maintenance of approved suppliers
• Review and establish appropriate inspection sample criteria and methods for all incoming components
• Support incoming inspections using appropriate methods, i.e., CMM, Vision Systems, gauges, etc.
• Initiate and process nonconformance reports for nonconforming product
• Manage equipment tracking, calibration and maintenance program
• Monitor label reconciliation activities and ensure a robust label reconciliation process
• Conduct in-process and final inspections of product prior to shipment
• Manage environmental controls and monitoring
• Review DHR prior to submission to Document Control for processing
• Determine 5S and lean manufacturing opportunities
• Identify areas of manufacturing where errors can be reduced and work with Project Manufacturing Engineers to implement error proofing methods

Qualifications

• Bachelor of Science Degree in Operations, Engineering or related field.
• Minimum of (5) years experience in regulated quality systems.
• Familiar with ISO13485:2016 and / or 21 CFR 820 requirements.
• Experience with 3rd party audits.

Job Type: Full-time

Pay: $60, $85,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Work Location: In person