Quality Engineer - Medical Devices | Process Control & CAPA

Ventura Solutions LLC; Norristown (Montgomery County); On-site; USD 75,000 - 110,000; Full time

Benefits offered by this job

Medical and dental insurance

Paid vacation time

401(k) after 90 days

Job summary

Ventura Solutions LLC in Norristown, PA seeks a Quality Engineer to support manufacturing operations. You will set basic quality standards for in-process and finished product testing and lead efforts to develop testing methods, sampling, and training.

Responsibilities include vendor qualification, DMRs, design control files, and CE technical files, with CAPA and supplier quality improvements. The role requires at least 2 years in Quality/Engineering, a bachelor's in a technical field, and the

Qualifications

• Bachelor's degree in Engineering, Science, Math, or another related technical field.
• At least 2 years of experience in Quality or Engineering.
• Experience developing ways of accomplishing goals with little supervision and good escalation judgment.

Responsibilities

• Manage methods and procedures for process control, validation, improvement, testing, and inspection to ensure product quality.
• Design experiments and apply SPC to analyze data and evaluate processes and changes.
• Perform testing and analysis to maintain quality and lead corrective actions for defects and trends.
• Collaborate with suppliers on quality issues, lead CAPA/SCAR programs, and supplier qualifications.
• Provide quality expertise in product development, design control, risk management, and CE technical files.
• Create device master records and support 510(k) submissions with regulatory and suppliers.

Skills

Time management

Problem solving

Independence

Attention to detail

Education

Bachelor's degree in Engineering/Science/Math

Tools

MS Office Suite

Microsoft Excel

Job description

Ventura Solutions LLC in Norristown, PA seeks a Quality Engineer to support manufacturing operations. You will set basic quality standards for in-process and finished product testing and lead efforts to develop testing methods, sampling, and training.

Responsibilities include vendor qualification, DMRs, design control files, and CE technical files, with CAPA and supplier quality improvements. The role requires at least 2 years in Quality/Engineering, a bachelor's in a technical field, and the