Quality Engineer

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

In this position, you will help develop, implement, and maintain the Quality Management System (QMS) to ensure our medical devices consistently meet quality and regulatory requirements. You will work closely with engineering and manufacturing teams to support product development, quality control, verification testing, and continuous improvement. This role includes ownership of internal and external product testing, quality documentation, and engineering support throughout the product lifecycle.

Key Responsibilities

• Maintain and improve the company's Quality Management System (QMS) in accordance with ISO 13485 and FDA Quality System Regulation (QMSR).
• Support product development by ensuring compliance with design control and quality system requirements.
• Create and maintain quality documentation, including Design History Files (DHF), change control documentation, and engineering records.
• Develop, execute, and document verification and validation (V&V) testing and design transfer.
• Plan and perform internal bench testing and engineering testing for product development and quality verification.
• Coordinate external testing with accredited laboratories for electrical safety, EMC, environmental, transportation, and other applicable testing.
• Write and maintain engineering test protocols, reports, and supporting quality documentation.
• Investigate test failures, nonconformances, complaints, and out-of-specifications (OOS) events in a methodical manner, applying statistical tools to support root cause analysis and corrective actions.
• Conduct trend analysis on quality events, including NCMs, OOS results, complaints, and service reports, to identify recurring issues and drive proactive quality improvements.
• Develop and maintain statistical sampling plans, in accordance with applicable ICH, ISO and guidance documents for validations and investigations.
• Participate in internal, supply and regulatory audits, CAPA activities, and field actions, where applicable.
• Develop quality metrics to monitor finished device quality, service/field performance, and other key quality indicators.
• Collaborate with engineering and manufacturing teams to ensure product quality throughout development and production.
• Support production quality activities, including inspection processes and manufacturing quality improvements.

Qualifications

Required:

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related engineering discipline.
• 5+ years of experience in medical device quality engineering or quality management.
• Familiarity with ISO 13485, FDA QMSR, Design Controls, Design History Files (DHF), and change control processes.
• Experience performing bench testing, verification testing, or product validation.
• Experience writing engineering test protocols and technical reports.
• Ability to read and interpret engineering drawings, GD&T, and component/parts datasheets.
• Proficiency with statistical tools and methods, e.g., SPC, sampling plans, hypothesis testing, trend/Cpk/Ppk analysis for data analysis and process control.
• Strong analytical, organizational, and problem‑solving skills.
• Excellent written and verbal communication skills.

Preferred:

• Familiarity with ISO 14971 risk management principles.
• Experience with CAPA, internal audits, and nonconformance investigations.
• Experience working with external testing laboratories.
• Experience supporting manufacturing quality and inspection activities.
• Knowledge of medical device verification and validation processes.

Physical Requirements

• Ability to work at a computer workstation for extended periods
• Occasional lifting of up to 25 lbs (test equipment, prototypes)
• Ability to work in a lab environment, including use of hand tools and test instrumentation
• Ability to travel domestically and internationally as needed.
• This role is based primarily in an office/lab setting, with occasional collaboration across manufacturing or production areas.