Quality Engineer - Medical Devices, Metrology & CAPA

Biomerics; Winston-Salem (NC); On-site; USD 70,000 - 100,000; Full time

Benefits offered by this job

Medical/Dental/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 advance quality initiatives by developing inspection, testing, and qualification activities aligned with customer and internal requirements. You will collaborate with Engineering, Production, and customers to resolve quality concerns and support new product introductions while ensuring compliance with design specifications.

You will develop metrology techniques, measurement fixtures, and data collection systems to drive continuous

Qualifications

• Engineering bachelor’s degree required or equivalent experience.
• 3–5 years quality experience (or 5+ with associate degree) or 10 years quality experience.
• ISO 9001:2015 and ISO 13485:2016 knowledge.
• Experience with PPAP, APQP, CAPA; PFMEA; Control Plans.
• Metrology experience with CMMs, optical comparators, and vision systems.
• Strong data analysis skills using Minitab and MS Office.

Responsibilities

• Support quality initiatives and improvements across the organization.
• Collaborate with Engineering, Production, and Customers to address quality concerns.
• Provide training on inspection methods and equipment to staff.
• Develop and qualify parts/assemblies per customer and internal requirements.
• Set up and monitor data collection systems for quality metrics.
• Interface with Engineering and Production on new products and lines.
• Lead part/assembly qualification activities and metrology challenges.
• Support testing such as force, gap, continuity, and hipot tests.

Skills

Quality engineering

Inspection methods

Customer communication

Continuous improvement

Statistical analysis

Education

Bachelor’s degree in Engineering

Associate degree with 5+ years quality experience

10+ years quality experience

Tools

CMM

Optical Comparator

Keyence Vision System

OGP / QVI

Minitab

Job description

Biomerics is seeking an experienced Quality Engineer to advance quality initiatives by developing inspection, testing, and qualification activities aligned with customer and internal requirements. You will collaborate with Engineering, Production, and customers to resolve quality concerns and support new product introductions while ensuring compliance with design specifications.

You will develop metrology techniques, measurement fixtures, and data collection systems to drive continuous