Senior Quality Engineer — Medical Devices & Metrology

Biomeric; Atwood (NC); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Short-Term Disability

Long-Term Disability

Life Insurance

Paid Vacation Days

Paid Holidays

401k

Job summary

Biomerics is seeking an experienced Quality Engineer to support and enhance quality initiatives in our medical device manufacturing environment. You will develop inspection, testing, and qualification activities, collaborate with Engineering, Production, and customers to address quality concerns, and ensure products meet design specifications.

You will coach Quality Lab personnel, implement metrology techniques, and lead data collection and continuous improvement efforts across parts and

Qualifications

• Engineering bachelor’s degree with 3–5 years QA experience, or associate degree with 5+ years QA, or 10 years QA experience.
• ISO 9001:2015 and ISO 13485:2016 experience.
• Experience with PPAP, APQP, CAPA, PFMEA, Control Plans, Flow Diagrams.

Responsibilities

• Supplement the Quality aspects of the organization.
• Interface with Customers for concerns, process changes, etc.
• Develop and perform inspection activities per customer and internal requirements.
• Setup and monitor data collection systems for quality metrics.
• Train quality and production personnel on inspection methods and equipment.
• Perform Part/Assembly qualification activities.
• Develop metrology techniques and fixtures to support part measurement.

Skills

Quality engineering

Problem solving

Communication

Continuous improvement

Data analysis

GD&T

Education

Bachelor's degree in Engineering

Associate degree +5 years QA

10+ years QA experience

Tools

Minitab

Excel

CMM/Keyence Vision

Gage R&R/GR&R

Job description

Biomerics is seeking an experienced Quality Engineer to support and enhance quality initiatives in our medical device manufacturing environment. You will develop inspection, testing, and qualification activities, collaborate with Engineering, Production, and customers to address quality concerns, and ensure products meet design specifications.

You will coach Quality Lab personnel, implement metrology techniques, and lead data collection and continuous improvement efforts across parts and