Quality Project Manager

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

We are 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.

Your Impact

• Own and manage the Corrective and Preventive Action (CAPA) process from initiation through effectiveness verification and closure.
• Lead structured root cause investigations, coordinating 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, trends, and systemic themes to Quality Management.
• Analyze data from complaints, nonconformities, returns, supplier performance, and inspection results to identify trends and continuous improvement opportunities.
• Lead cross-functional quality projects involving remediation plans, validation activities, regulatory and standards transitions, and electronic quality management system changes.
• Maintain project trackers identifying project owners, deliverables, and due dates, and provide project summaries for Management Review.
• Coordinate the internal audit program, including audit scheduling, scope, auditor assignments, finding classification, and closure of findings.
• Coordinate validation of quality management system software applications and maintain revalidation records following configuration changes.
• Perform first production lot inspections for new and changed part numbers using calibrated inspection equipment and document results according to established procedures.
• Perform targeted inspections on parts with elevated nonconformance, complaint, or return rates to support data analysis and improvement initiatives.
• Provide backup inspection support during employee absences or production surges, including magnification inspection of small-font laser etching.
• Support quality and regulatory activities associated with product commercialization, including 510(k) submission packaging and Management Review.
• Apply working knowledge of applicable medical device regulations and standards, including ISO 13485:2016, 21 CFR Part 820, and ISO 14971:2019.

What You Bring

• 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. Medical device experience is preferred.
• 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.
• Ability to use calipers, micrometers, and mechanical inspection instrumentation. RAM and Overlay experience is a plus.
• Proficiency with Microsoft Office and experience with CAD software; Creo preferred.
• Experience with or willingness to train and/or obtain certifications related to ISO 13485, ISO 14971, cGMP, and other quality and regulatory systems supporting medical device compliance and safety.
• Valid driver's license.
• Strong organizational skills with a detail-oriented and quality-focused approach.
• Excellent communication and customer service skills, with the ability to conduct investigations with tact and professionalism.

What We Offer

• Multiple health insurance plans, including a no-cost HSA health plan for eligible employees
• Affordable dental and vision benefits
• 100% paid uniforms
• 401(k) with employer match
• 100 hours of PTO during your first year
• Group Life Insurance
• Seven paid holidays every year
• Investing in you: paid training for certifications and licenses