Overview
Skills
Job Details
Position Summary
The Quality Engineer supports all departmental activities with a focus on compliance, continuous improvement, and quality-by-design. Key responsibilities include documenting system enhancements for product and service compliance, partnering with customers and production teams, and driving corrective actions and ongoing improvements throughout the product lifecycle. This is a fully on-site role based in Horsham, PA.
Essential Duties & Responsibilities
(Responsibilities include, but are not limited to the following)
Quality Systems & Compliance
Oversee ISO 13485 (and related regulatory) subsystems for Design & Development, Validation, Change Control, and Calibration.
Conduct and facilitate internal audits to ensure long-term compliance.
Data Analysis & Continuous Improvement
Track, trend, and analyze manufacturing and quality performance; initiate projects to increase efficiency, reduce cost, simplify processes, and improve quality.
Lead in-house problem-solving and troubleshooting for long-term issue resolution.
Nonconformance & CAPA Management
Support or lead investigations, root-cause analyses, and corrective actions using CAPA and RCA tools.
Validation & Testing
Coordinate equipment, process, test-method, and software validations (protocol generation, execution, and reporting).
Project & Portfolio Leadership
Serve as project manager for quality-related initiatives, providing timely updates and ensuring accountability to schedules.
Act as quality lead on Design & Development projects, guiding successful design transfer to production.
Statistical & Experimental Methods
Develop sampling plans, inspection/test methods, and statistical tools to support process control and product improvements.
Customer & Supplier Interface
Provide technical support to customers and suppliers; ensure incoming-material quality.
Documentation & Training
Develop and maintain QMS documentation; deliver training to ensure repeatable control and best practices.
Qualifications & Requirements
Education: Bachelor s degree required (Life-Science discipline preferred).
Experience: 3 5 years in quality control, quality assurance, or engineering within a regulated manufacturing environment.
Standards & Regulations: Hands-on knowledge of ISO 9001, ISO 13485, FDA/QSR, Good Documentation Practices, and process validation.
Technical Skills:
Strong analytical and mathematical ability.
Proficient in Microsoft Word, Excel, Outlook; eQMS or ERP experience highly desired.
Excellent technical writing; meticulous attention to detail.
Soft Skills:
Independent, organized, and deadline-driven with strong interpersonal skills.
Effective communicator in one-on-one and group settings; able to present technical information clearly.
Committed to company values, professional conduct, and respectful collaboration.
Other Requirements:
Ability to wear appropriate PPE and follow all safety protocols.
Occasional travel (< 15%, domestic and international).
Work Environment & Physical Requirements
Primarily office-based with regular exposure to manufacturing and warehouse areas.
Potential exposure to hazardous chemicals; PPE required where applicable.
Physical demands are typical for an office/manufacturing hybrid role; reasonable accommodations may be made for individuals with disabilities.