Quality Engineer

Biomerics LLC; Winston-Salem (NC); On-site; USD 80,000 - 110,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Short-Term Disability

Long-Term Disability

Life Insurance

Paid Vacation

Paid Holidays

401k

Job summary

Biomerics LLC is seeking an experienced Quality Engineer to advance quality initiatives and qualification activities. You will collaborate with Engineering, Production, and customers to address quality concerns, while developing metrology techniques and testing methods to drive continuous improvement.

You will train Quality Lab staff on inspection methods and tools, support part/assembly qualifications, and perform specialized tests such as force, gap, continuity, and hipot to ensure product

Qualifications

• Engineering degree and 3–5 years QA experience, or an associate degree with 5+ years QA experience
• Must work safely per ISO 9001:2015 and ISO 13485:2016
• Experience with PPAP, APQP, CAPA and 8D/3L5Y/Fishbone problem solving
• MS Office proficiency and SPC data analysis using Minitab

Responsibilities

• Support and enhance quality initiatives via inspection, testing, and qualification activities
• Collaborate with Engineering, Production, and customers to address quality concerns
• Develop metrology techniques, fixtures, and performance testing methods
• Provide training to Quality Lab Inspectors, Technicians, and production personnel
• Perform part/assembly qualifications and support force, gap, continuity, and hipot testing

Skills

Quality mindset

Interpersonal skills

Continuous improvement

Goal oriented

Education

Engineering bachelor's degree

Associate degree +5 years QA experience

10+ years QA experience

Tools

Minitab

CMM

OGP / QVI

Optical Comparator

Keyence Vision System

Job description

Company Overview

Biomerics is a world-class manufacturer and innovative polymer solutions provider for the medical device and biotech industries. As a vertically integrated company, we specialize in designing, developing, and producing medical devices for diagnostic and interventional procedures. We are focused on next-generation solutions for vascular access, electrophysiology, cardiac rhythm management, neurovascular, structural heart, and cardiovascular markets.

At Biomerics, we are dedicated to our diverse employee base. We understand that a strong, skilled, and engaged workforce is the foundation of our continued success as a business. We strive to live up to the Biomerics values in all our interactions. It is an exciting time to be part of our collective team, and there is no limit to the impact that can be achieved here at Biomerics.

We improve and advance our employees' lives and the lives of the patients who depend on our products.

At Biomerics, we are guided by our core values of integrity, partnership, empowerment & accountability, trust, agility, teamwork, and excellence. We deeply care about our team members and customers, and our team-oriented, customer-focused corporate culture places a premium on building strategic, mutually beneficial partnerships. Joining our team means becoming part of a dynamic, innovative, and caring community.

JOB SUMMARY

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 timesISO 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

Why Join Biomerics?

At Biomerics, you will be part of a collaborative and growth-oriented organization dedicated to improving lives through innovation and manufacturing excellence. We value individuals who are passionate about building strategic customer partnerships and driving operational and commercial success within the medical device industry.

Benefits

Medical/Dental/Vision Insurance, Short-Term Disability, Long-Term Disability, Life Insurance, Paid Vacation Days, Paid Holidays, 401k.

The salary estimates are estimates from this job board and not a guarantee from Biomerics' salary range.

Biomerics does not accept non-solicited