Manufacturing Quality Engineer

Drummond Scientific Company; Broomall (PA); On-site; USD 80,000 - 100,000; Full time

Job summary

Drummond Scientific Company, located just outside of Philadelphia, PA, is seeking a Manufacturing Quality Engineer to ensure product quality and process integrity across the lifecycle. You will support new product development and ongoing production, maintaining QMS in line with ISO 13485 and FDA QSR.

You will lead audits, drive CAPA and supplier improvement, and collaborate with BD and Engineering to develop inspection plans for new products.

Qualifications

• Bachelor’s degree in engineering inMechanical, Biomedical, Industrial, or related field.
• Experience in a regulated manufacturing environment.
• Experience with CAPA, root cause analysis tools (5 Whys, Fishbone), and IQ/OQ/PQ validation.
• Proficiency with statistical analysis and quality tools.

Responsibilities

• Maintain and improve the QMS in alignment with ISO 13485, FDA QSR, and internal procedures.
• Perform process mapping, FMEA, and statistical assessments.
• Support production teams in resolving quality issues and implementing CAPA.
• Analyze manufacturing processes using SPC, DOE, MSA for data-driven decisions.
• Lead and support audits and regulatory inspections.
• Review inspection and sampling plans; improve QA documentation.
• Assist BD and Engineering in developing inspection plans for new products.
• Participate in design reviews ensuring Design Development compliance.
• Support V&V activities, including test method validation.
• Evaluate suppliers and monitor supplier performance metrics.
• Drive supplier corrective actions and continuous improvement initiatives.
• Analyze quality data for trends and process capability.
• Use Excel for statistical analysis.
• Contribute to CAPA, NCRs, complaint handling, and document control.
• Prepare quality reports for management including KPIs and CAPA status.

Skills

Analytical skills

Problem solving

Communication

Cross-functional collaboration

CQE/CQA certifications (plus)

Education

Bachelor’s degree in engineering

Tools

GDT

Tolerancing analysis

Job description

*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.

Pay: $90,000 per year

Scope of Position

This role focuses on product quality and process integrity across the manufacturing

lifecycle, supporting both new product development and ongoing production. The Manufacturing Quality Engineer ensures that all products are designed, manufactured, and distributed in compliance with regulatory and customer requirements.

Key Responsibilities

• Maintain and improve the Quality Management System (QMS) in alignment with ISO 13485, FDA QSR, and internal procedures.
• Process mapping, FMEAs, and statistical assessments.
• Support production teams in resolving quality issues, identifying root causes, and implementing corrective and preventive actions.
• Evaluate, monitor, and improve manufacturing processes using statistical tools (SPC, DOE, MSA) to support data-driven decision-making.
• Lead and support audits (internal & external), and regulatory inspections.
• Analyze existing inspection plans, sampling plans, and quality control documentation. Make improvements where necessary.
• Assist Business Development and Engineering teams in developing inspection and sampling plans for new products.
• Participate in design reviews, ensuring compliance with Design Development requirements.
• Support verification and validation (V&V) activities, including test method validation.
• Assist with evaluation of suppliers; maintain supplier performance metrics.
• Drive supplier corrective actions and continuous improvement initiatives.
• Analyze quality data to identify trends, process capability, and improvement opportunities.
• Use Excel for statistical analysis.
• Assist with quality system elements such as CAPA, NCRs, complaint handling, and document control.
• Prepare quality reports for management, including KPIs, audit findings, and CAPA status.

Qualifications

• Bachelor’s degree in engineering (Mechanical, Biomedical, Industrial, or related field).
• Experience working in a regulated manufacturing environment.
• Experience with CAPA, root cause analysis tools (5 Whys, Fishbone), and process validation (IQ/OQ/PQ).
• Proficiency with statistical analysis and quality tools.

Desired Skills & Abilities

• Strong analytical and problem-solving skills.
• Working knowledge of ISO 13485, 21 CFR Part 820, ISO 14971, and GMP.
• Familiar with GDT and tolerancing analysis.
• Ability to interpret engineering drawings and specifications.
• Excellent communication and cross-functional collaboration.
• Detail-oriented mindset with a commitment to product safety and compliance.
• ASQ certifications (CQE, CQA) are a plus.
• Ability to manage multiple priorities in a fast-paced environment.