On-Site Manufacturing Quality Engineer – PA

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

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.