Now Hiring: Quality Project ManagerFull-Time| On-Site| West Chester, PA
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.
What We Offer - Competitive salary
- 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
- Work-Life Services Benefit Program (Employee + Family)
- Group Life Insurance
- Seven paid holidays every year
- Investing in you: paid training for certifications and licenses
- Wellness Coach Program access
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.
