Quality Engineer Miller Technical Services (MTS) - 1.0 Plymouth, MI Job Details Full-time $60,000 - $85,000 a year 13 hours ago Benefits Health insurance Dental insurance 401(k) Paid time off Vision insurance Qualifications Bachelor of Science Biomedical regulatory compliance

FMEA PPAP ISO 13485 FDA

regulations Full Job Description 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:

$60,000.00 - $85,000.00 per year

Benefits:

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

Work Location:

In person