QA/QE Engineer

JOB SUMMARY

The QA/QE Engineer supports Quality Assurance and Engineering functions in an aerospace and medical device manufacturing environment. This role is ideal for a developing engineer ready to grow in root cause analysis, continuous improvement, CAPA, risk management, and process/test method validation. Under the guidance of the Quality and Regulatory Manager, this role supports shop floor operations while collaborating with engineering to improve processes and compliance to industrial/regulatory standards.

RESPONSIBILTIES

RQuality Assurance & Inspection

• Perform incoming, in-process, and final inspections using hand tools, gauges, and visual inspection equipment (Smartscope/OGP/Keyence).
• Verify conformance to engineering drawings, specifications, and customer requirements (GD&T).
• Create and maintain inspection records, Certificates of Conformance (CoC), and quality documentation.
• Identify nonconformances (NCMRs) and support MRB disposition and rework documentation.
• Prepare records for internal, customer, and regulatory audits (FDA, FAA, AS9100/ISO13485).

Quality Engineering & Compliance

• Assist in developing Control Plans, PFMEAs, and basic DFMEA support.
• Perform First Article Inspections (FAIs) per AS9102, including dimensional layouts.
• Support CAPA data collection, root cause analysis (5 Whys, Fishbone, 8D, Is/Is Not), and continuous improvement.
• Assist with process validations (IQ/OQ/PQ) and Test Method validations (Gage R&R, MSA).
• Support QMS maintenance in compliance with AS9100, ISO 13485, and FDA 21 CFR Part 820.
• Draft and revise SOPs, work instructions, and quality forms with cross-functional teams.

REQUIREMENTS

• Ability to read and interpret engineering drawings; understanding of GD&T (ASME Y14.5).
• Experience with with calipers, micrometers, indicators, pin gauges, and other precision Measurement Test and Equipment (MT&E).
• Change Control Processes
• Validation & Verification processes
• Basic experience with vision inspection equipment or willingness to be trained
• Working knowledge of Microsoft Office (Excel, Word, Outlook), Minitab or similar data analysis tools; ability to handle data entry and basic analysis.
• Quality Knowledge (Foundational):
• Awareness of key standards such as AS9100, ISO 13485, ISO14971 and ISO3100.
• Basic understanding of nonconformance handling, CAPA, and documentation control.
• Exposure to FMEA, SPC, or root cause analysis tools (even at a classroom or project level).
• US Persons (ITAR Regulations)
• Able to work under FFL (Federal Firearms License) No Felony or Domestic Violence Convictions

EDUCATION & EXPERIENCE

• Bachelor’s degree in: Mechanical Engineering, Industrial Engineering, Manufacturing Engineering, or related technical field OR Bachelor’s/Associate degree plus strong relevant experience in quality or precision manufacturing.
• Exposure to aerospace, medical device, or other highly regulated industries with knowledge of regulatory/industrial requirements.
• ASQ certified quality engineer or Six Sigma Greenbelt (ASQ CQE/SSGB) preferred.

PHYSICAL DEMANDS

• 25-50% Travel
• 10 lb lifting

GMI C3 A.R.E Values

As employee-owners, these are the Values that guide us through our work and relationships at GMI.

• Customer Focused
• Consistency
• Communication/Collaboration
• Accountability
• Reliability
• Engagement of Culture