Quality Engineer

BIOMERICS LLC•Winston-Salem, NC

About The Position

Biomerics is seeking an experienced Quality Engineer to support and enhance organizational quality initiatives by developing and executing inspection, testing, and qualification activities that meet customer and internal requirements. Collaborate with Engineering, Production, and customers to address quality concerns, support new product introductions, and ensure product compliance with design specifications. Develop metrology techniques, measurement fixtures, and performance testing methods, while establishing and monitoring data collection systems to drive continuous improvement. Provide technical guidance and training to Quality Lab Inspectors, Technicians, and production personnel on inspection methods, equipment, and customer quality expectations. Perform part and assembly qualifications and support testing such as force, gap, continuity, and high-potential (hipot) testing. Supplement the Quality aspects of the organization. Participate in quality improvements of the company. Give direction to production personnel as to Customer expectations and requirements for products. Interface with Customers for concerns, process changes, etc. Train production and other Quality personnel on use of inspection equipment. Develop and perform inspection activities per customer and internal requirements. Setup and monitor data collection systems. Interface with Engineering and Production on new products and product lines. Perform Part/Assembly qualification activities. Develop necessary metrology techniques and fixtures to support part measurement. Develop performance characterizations such as force testing, gap testing, continuity tests, hi-pot tests etc.

Requirements

In-depth knowledge of manufacturing processes, Injection Molding, Metal Stamping, & Assembly
Engineering bachelor’s degree and 3-5 years Quality experience, or associate degree with 5+ years Quality experience, or minimum 10 years quality experience.
Must be goal oriented, with strong interpersonal skills, continuous improvement skills, quality inspection skills, customer communication skills, and continuous improvement skills. If selection is internal have demonstrated solid product knowledge
Must work safely at all times
ISO 9001:2015 and ISO 13485:2016
Medical Validation - IQ, OP, PQ Experience – Protocols
PPAP – Production Part Approval Process
APQP – Advanced Product Quality Planning
Core Documents: Control Plans, PFMEA, Flow Diagrams, Work Instructions, & Inspection Instructions
GR&R – Gage Repeatability & Reproducibility
MSA – Measurement System Analysis
CAPA – Corrective Action / Preventive Action
Advanced Problem-Solving Techniques - 8D, 3L5Y, Fishbone
Metrology Experience - OGP / QVI / Optical Comparator / CMM / Keyence Vision System & Handheld Equipment
Print Reading / Advanced GD&T Experience
Strong Microsoft Office Knowledge: Excel, Word, PowerPoint
SPC - Statistical Process Control and evaluation
Data Analytical Skills – Minitab Software

Responsibilities

Supplement the Quality aspects of the organization.
Participate in quality improvements of the company.
Give direction to production personnel as to Customer expectations and requirements for products.
Interface with Customers for concerns, process changes, etc.
Train production and other Quality personnel on use of inspection equipment.
Develop and perform inspection activities per customer and internal requirements.
Setup and monitor data collection systems.
Interface with Engineering and Production on new products and product lines.
Perform Part/Assembly qualification activities.
Develop necessary metrology techniques and fixtures to support part measurement.
Develop performance characterizations such as force testing, gap testing, continuity tests, hi-pot tests etc.