Quality Project Manager: CAPA & Cross‑Functional Leader

Altus Spine; West Chester (Chester County); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Health insurance plans

No-cost HSA health plan

Dental and vision benefits

401(k) with employer match

Paid time off

Group Life Insurance

Paid holidays

Training and certifications

Wellness coaching

Job summary

Altus Spine is seeking a Quality Project Manager to lead CAPA investigations, root cause analysis, and cross-functional quality projects while supporting inspection, compliance, and continuous improvement across the product lifecycle.

The role focuses on CAPA ownership, data-driven improvements, and collaboration across Engineering, Operations, Suppliers, and Customers. Medical device experience is preferred and ISO 13485, ISO 14971 knowledge is valued.

Qualifications

• Experience owning CAPA investigations from initiation through verification and closure.
• Experience managing cross-functional quality projects with defined scope and timelines.
• Working knowledge of medical device regulations, ISO standards, and quality management systems.
• Strong analytical, problem-solving, and data-driven decision-making.
• Excellent communication and documentation skills.

Responsibilities

• Own and manage the CAPA process from initiation through effectiveness verification and closure.
• Lead root cause investigations with input from Engineering, Operations, Suppliers and Customers.
• Establish verification methods and evidence requirements for CAPA activities.
• Maintain CAPA records, aging metrics, and elevation to Quality Management.
• Analyze complaints, nonconformities, returns, and supplier performance for trends.
• Lead cross-functional quality projects including remediation plans and regulatory transitions.
• Maintain project trackers and provide summaries for Management Review.
• Coordinate internal audit program scheduling, scope, and findings closure.
• Coordinate validation of quality management system software and revalidation records.
• Perform inspections on new/changed parts and targeted inspections for data analysis.
• Support product commercialization activities including 510(k) packaging.
• Apply knowledge of ISO 13485, 21 CFR Part 820, and ISO 14971:2019.

Skills

CAPA investigations

Root cause analysis

Cross-functional project management

Quality systems

Regulatory compliance

Data analysis

Documentation controls

Education

Bachelor's degree in Engineering or technical field

Associate's degree + 7+ years experience

Tools

Creo

Calipers & micrometers

Inspection equipment

Job description

Altus Spine is seeking a Quality Project Manager to lead CAPA investigations, root cause analysis, and cross-functional quality projects while supporting inspection, compliance, and continuous improvement across the product lifecycle.

The role focuses on CAPA ownership, data-driven improvements, and collaboration across Engineering, Operations, Suppliers, and Customers. Medical device experience is preferred and ISO 13485, ISO 14971 knowledge is valued.