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À propos
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
Quality 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
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. REQUIREMENTS
Technical Skills:
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 US Person as required by ITAR FFL eligible (Firearms Mfg.)
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).
PHYSICAL DEMANDS & PPE REQUIREMENTS
25-50% of standing, walking production floor 10 Lb lifting, pushing, pulling
Compétences linguistiques
- English
Avis aux utilisateurs
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