Senior Medical Device Quality Engineer - QMS & V&V

Bechtel Medical Inc.; Phoenixville (Chester County); On-site; USD 90,000 - 130,000; Full time

Job summary

Bechtel Medical Inc. seeks a Quality Engineer to develop, implement, and maintain the Quality Management System for medical devices, aligning with ISO 13485 and FDA QMSR.

You will partner with engineering and manufacturing to support product development, quality control, verification testing, and continuous improvement. Responsibilities include DHF and change control documentation, V&V testing, internal/external testing coordination, and root-cause analysis of test failures and OOS events.

Qualifications

• Bachelor's degree in Mechanical/Biomedical engineering or related field.
• 5+ years in medical device quality engineering or quality management.
• Experience with ISO 13485, FDA QMSR, Design Controls, and DHF/change control.
• Experience bench testing, verification testing, or product validation.
• Experience writing test protocols and technical reports.
• Ability to read GD&T drawings and datasheets.
• Statistical tools knowledge: SPC, sampling plans, hypothesis testing, trend/Cpk/Ppk.

Responsibilities

• Maintain and improve the Quality Management System per ISO 13485 and FDA QMSR.
• Support product development ensuring design control and quality system compliance.
• Create and maintain quality documentation including DHF and change control.
• Develop, execute, and document verification and validation testing and transfer.
• Plan and perform internal bench testing and engineering testing for development and quality verification.
• Coordinate external testing with accredited laboratories for various testing.
• Write and maintain engineering test protocols, reports, and quality documentation.
• Investigate test failures, nonconformances, complaints, and OOS events with root cause analysis.
• Conduct trend analysis on quality events to identify recurring issues and improvements.
• Develop statistical sampling plans for validations and investigations per guidelines.
• Participate in internal, supplier and regulatory audits, CAPA, and field actions where applicable.
• Develop quality metrics to monitor finished device quality and field performance.
• Collaborate with engineering and manufacturing to ensure product quality throughout lifecycle.
• Support production quality activities including inspection processes and improvements.

Skills

Analytical thinking

Organizational skills

Problem-solving

Communication skills

Education

Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or related engineering

Tools

SPC

Sampling plans

Hypothesis testing

Cpk/Ppk analysis

Job description

Bechtel Medical Inc. seeks a Quality Engineer to develop, implement, and maintain the Quality Management System for medical devices, aligning with ISO 13485 and FDA QMSR.

You will partner with engineering and manufacturing to support product development, quality control, verification testing, and continuous improvement. Responsibilities include DHF and change control documentation, V&V testing, internal/external testing coordination, and root-cause analysis of test failures and OOS events.