Quality Engineer

Applicants must be authorized to work in the U.S. without current or future visa sponsorship. This role is fully on-site and based in Broomall, PA. We are unable to offer relocation assistance for this role. Company: Drummond Scientific Company, located just outside of Philadelphia, PA, is a family‑owned company that leverages nearly 75 years of experience to maintain its position as an elite developer and manufacturer of consumable medical devices, which includes both microvolume liquid transfer technology and rapid diagnostics. Our branded products can be found in laboratories across the globe and are continuously recognized for their durability and reliability. Despite the notoriety gained from the products bearing the Drummond name, what truly establishes the company as an industry leader is its role as a contract manufacturer. Parts made by Drummond have helped create and save lives by revolutionizing the field of in vitro fertilization and enabling the diagnostic technologies of many of the largest, and most innovative, companies in the world. Scope of Position The Quality Engineer ensures that all medical devices are designed, manufactured, and distributed in compliance with FDA 21 CFR Part 820 , ISO 13485 , and other applicable regulatory and customer requirements. This role drives product quality, process capability, and continuous improvement across the manufacturing lifecycle, supporting both new product development and ongoing production. Key Responsibilities Maintain and improve the Quality Management System (QMS) in alignment with ISO 13485 , FDA QSR , and internal procedures. Lead and support internal audits, supplier audits, and regulatory inspections. Own and manage quality system elements such as CAPA, NCRs, complaint handling, and document control. Develop, validate, and monitor manufacturing processes using statistical tools (SPC, DOE, MSA). Support production teams in resolving quality issues, identifying root causes, and implementing corrective and preventive actions. Create and maintain inspection plans, sampling plans, and quality control documentation. Participate in design reviews, ensuring compliance with Design Control requirements. Support verification and validation (V&V) activities, including test method validation. Evaluate and qualify suppliers; maintain supplier performance metrics. Review and approve supplier PPAPs, first article inspections, and material certifications. Drive supplier corrective actions and continuous improvement initiatives. Analyze quality data to identify trends, process capability, and improvement opportunities. Prepare quality reports for management, including KPIs, audit findings, and CAPA status. Use statistical software (e.g., Minitab) to support data‑driven decision‑making. Qualifications Bachelor’s degree in engineering (Mechanical, Biomedical, Industrial, or related field). 2–5 years of experience in a regulated manufacturing environment; medical device experience strongly preferred. Working knowledge of ISO 13485 , 21 CFR Part 820 , ISO 14971 , and GMP. Experience with CAPA, root cause analysis tools (5 Whys, Fishbone), and process validation (IQ/OQ/PQ). Proficiency with statistical analysis and quality tools (SPC, MSA, DOE). ASQ certifications (CQE, CQA) are a plus. Desired Skills & Abilities Strong analytical and problem‑solving skills. Ability to interpret engineering drawings and specifications. Excellent communication and cross‑functional collaboration. Detail‑oriented mindset with a commitment to product safety and compliance. Ability to manage multiple priorities in a fast‑paced environment. #J-18808-Ljbffr