Quality Project Lead — CAPA & Compliance

Altus Spine; Chester (Delaware County); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Health insurance

Dental and vision

401(k) with match

PTO 100 hours

Uniforms provided

Life Insurance

Paid holidays

Training for certifications

Wellness program

Job summary

Altus Spine is seeking a Quality Project Manager to drive CAPA investigations, root cause analyses, and cross-functional quality initiatives across the product lifecycle. You will lead data-driven improvements, manage audits, and ensure regulatory compliance while collaborating with Engineering, Operations, and Suppliers.

The role requires strong project management, QA systems knowledge, and hands-on inspection expertise in a regulated medical device environment.

Qualifications

• Bachelor's degree in Engineering or a technical field plus 5+ years of experience; Associate's degree plus 7+ years; or High School diploma plus 10+ years of experience in a quality or engineering role within a regulated environment.
• Experience owning CAPA investigations from initiation through verification and closure.
• Experience managing cross-functional projects with defined scope, schedules, and deliverables.

Responsibilities

• Own and manage the CAPA process from initiation through effectiveness verification and closure.
• Lead structured root cause investigations, coordinating input from Engineering, Operations, Suppliers, and Customers.
• Establish effectiveness verification methods and evidence requirements for CAPA activities and ensure effectiveness before closure.
• Maintain CAPA records, aging metrics, and escalation activities; present CAPA status and themes to Quality Management.
• Analyze data from complaints, nonconformities, returns, and supplier performance to identify trends and improvements.
• Lead cross-functional quality projects with remediation plans and regulatory transitions.
• Maintain project trackers with owners, deliverables, and due dates; provide summaries for Management Review.
• Coordinate the internal audit program including scheduling, scope, and findings closure.
• Coordinate validation of QMS software and maintain revalidation records after changes.
• Perform first production lot inspections using calibrated equipment and document results per procedures.
• Perform targeted inspections on parts with high nonconformance or returns to support data analysis.
• Provide backup inspection support during absences and surges; assist with laser etching inspections.
• Support quality and regulatory activities for product commercialization, including 510(k) submission packaging and Management Review.
• Apply knowledge of medical device regulations and standards including ISO 13485:2016, 21 CFR Part 820, ISO 14971:2019

Skills

CAPA investigations

Root cause analysis

Cross-functional leadership

Data analysis

Quality systems

ISO knowledge

Inspection methods

Education

Bachelor's degree in Engineering

Associate's degree in engineering

High School diploma

Tools

Creo

Microsoft Office

Job description

Altus Spine is seeking a Quality Project Manager to drive CAPA investigations, root cause analyses, and cross-functional quality initiatives across the product lifecycle. You will lead data-driven improvements, manage audits, and ensure regulatory compliance while collaborating with Engineering, Operations, and Suppliers.

The role requires strong project management, QA systems knowledge, and hands-on inspection expertise in a regulated medical device environment.