Quality Project Lead - CAPA & Continuous Improvement

Acero Precision; West Chester (Chester County); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Health insurance

Dental and vision benefits

401(k) with match

Paid time off

Job summary

Altus Spine, a medical device company focused on quality and patient safety, seeks a Quality Project Manager to lead CAPA investigations, root cause analysis, and cross-functional quality projects across the product lifecycle.

You will maintain CAPA records, coordinate internal audits, validate quality management system changes, and ensure regulatory compliance under ISO 13485 and 21 CFR Part 820.

Qualifications

• Bachelor's degree in Engineering or technical field with 5+ years in quality/regulated environments.
• Experience owning CAPA investigations end-to-end and closure.
• Experience managing cross-functional projects with defined scope and deliverables.
• Knowledge of medical device regulations and quality management systems.

Responsibilities

• Own and manage CAPA from initiation to closure with verification of effectiveness.
• Lead root cause investigations across Engineering, Operations, Suppliers and Customers.
• Establish verification methods and evidence requirements for CAPA activities.
• Maintain CAPA records, aging metrics, and escalation activities for Management Review.
• Coordinate internal audit program and audit findings closure.
• Validate quality management system software and perform revalidation after changes.
• Perform first production lot inspections and targeted inspections on high-nonconformance parts.

Skills

CAPA investigations

Root cause analysis

Cross-functional leadership

Data analysis

Quality systems

ISO 13485

21 CFR Part 820

Creo

Education

Bachelor's degree in Engineering

Associate's degree in Engineering

High School diploma

Tools

CAD software

Job description

Altus Spine, a medical device company focused on quality and patient safety, seeks a Quality Project Manager to lead CAPA investigations, root cause analysis, and cross-functional quality projects across the product lifecycle.

You will maintain CAPA records, coordinate internal audits, validate quality management system changes, and ensure regulatory compliance under ISO 13485 and 21 CFR Part 820.