Medical Device Quality Engineer – Validation & Improvement

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

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