Quality Project Manager: CAPA & Compliance Lead

Brightpath Associates LLC; Pennsylvania; On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Health insurance plans

Dental and vision benefits

Uniforms provided

401(k) with employer match

100 hours of PTO in first year

Group Life Insurance

Paid holidays

Certifications and licenses training

Job summary

Brightpath Associates LLC seeks a Quality Project Manager to lead CAPA investigations, root cause analysis, and cross-functional quality projects across the product lifecycle. You will support inspection, compliance, and continuous improvement within a regulated medical-device environment.

Responsibilities include managing CAPA from initiation to closure, coordinating cross-functional RCA, establishing verification methods, and presenting CAPA trends to management.

Qualifications

• Bachelor's degree in Engineering or a technical field plus 5+ years of experience in quality or engineering in a regulated environment.
• Experience owning CAPA investigations from initiation through effectiveness verification and closure.
• Experience managing cross-functional projects with defined scope, schedules, and deliverables.
• Experience with root cause analysis, risk-based analysis, and quality systems within a regulated environment.
• Working knowledge of medical device regulations, ISO standards, and quality management systems.
• Proficiency with Microsoft Office and experience with CAD software; Creo preferred.

Responsibilities

• Own and manage the CAPA process from initiation through effectiveness verification and closure.
• Lead structured root cause investigations with cross-functional input from Engineering, Operations, Suppliers, and Customers.
• Establish effectiveness verification methods and evidence requirements for CAPA activities and ensure effectiveness is demonstrated prior to closure.
• Maintain CAPA records, aging metrics, and escalation activities while presenting CAPA status and trends to Quality Management.
• Analyze data from complaints, nonconformities, returns, supplier performance, and inspection results to identify trends and improvement opportunities.
• Lead cross-functional quality projects involving remediation plans, validation activities, and regulatory transitions.

Skills

CAPA investigations

Root cause analysis

Cross-functional PM

Regulated environment

Communication

Detail-oriented

Education

Bachelor's degree in Engineering/technical field

Associate's degree +7 years

High School +10 years experience

Tools

Creo

CAD software

Microsoft Office

Calipers & micrometers

Job description

Brightpath Associates LLC seeks a Quality Project Manager to lead CAPA investigations, root cause analysis, and cross-functional quality projects across the product lifecycle. You will support inspection, compliance, and continuous improvement within a regulated medical-device environment.

Responsibilities include managing CAPA from initiation to closure, coordinating cross-functional RCA, establishing verification methods, and presenting CAPA trends to management.