On-Site Quality Engineer I: Inspection & CAPA Projects

Altus Spine; West Chester (Chester County); On-site; USD 65,000 - 72,000; Full time

Benefits offered by this job

Health insurance

Dental & vision

Uniforms provided

401(k) with match

Paid time off

Life insurance

Holidays

Training for certifications

Wellness program

Job summary

Altus Spine in West Chester, PA, on-site, is hiring a Quality Engineer I - Inspection and Project Management. You will perform hands-on dimensional inspections and lead CAPA investigations, root cause analysis, and cross-functional quality projects across the product lifecycle.

The role requires hands-on measurement with calipers/micrometers, inspection equipment, and strong data analysis to identify trends and drive corrective actions.

Qualifications

• Bachelor's degree in engineering or technical field with related experience.
• Experience owning CAPA investigations from initiation to closure.
• Hands-on measurement experience with calipers, micrometers, gauges.
• Knowledge of ISO 13485, ISO 14971, cGMP and medical device quality systems.

Responsibilities

• Perform first article and first production inspections using calibrated equipment.
• Lead CAPA investigations from initiation to effectiveness verification and closure.
• Analyze quality data, drive cross-functional investigations and corrective actions.
• Manage quality projects with remediation plans, validation activities and timelines.
• Coordinate internal audits and support Management Review and QMS requirements.

Skills

CAPA investigations

Dimensional inspection

Root cause analysis

Cross-functional projects

Quality systems

Education

Bachelor's degree in Engineering or technical field

Tools

Calipers

Micrometers

Optical comparators

Vision measurement systems

Gauges (pin & thread)

CAD software (Creo)

Job description

Altus Spine in West Chester, PA, on-site, is hiring a Quality Engineer I - Inspection and Project Management. You will perform hands-on dimensional inspections and lead CAPA investigations, root cause analysis, and cross-functional quality projects across the product lifecycle.

The role requires hands-on measurement with calipers/micrometers, inspection equipment, and strong data analysis to identify trends and drive corrective actions.