Quality Assurance Engineer: Process & Compliance Champion

Comrise; Mahwah (NJ); On-site; USD 85,000 - 110,000; Full time

Job summary

Comrise is seeking a Quality Assurance Engineer in a medical device-oriented manufacturing environment located in New Jersey. The role emphasizes quality assurance, control, and continuous improvement to ensure product quality and regulatory compliance.

The ideal candidate will have hands-on experience with FAI, PPAP, change control, SOP maintenance, and risk management within ISO 13485/GMP/GDP frameworks, and will work both independently and with cross-functional teams to drive operational

Qualifications

• Bachelor's degree in a technical field relevant to quality engineering (Biomedical/Mechanical preferred).
• At least 2 years of quality engineering/QA in manufacturing or related industry.
• Experience with change management and Quality Management System (QMS) principles.
• Familiarity with FAI, PPAP, process validation, and engineering change controls is highly desirable.
• Knowledge of medical device quality systems, ISO 13485, GDP, GMP is advantageous.

Responsibilities

• Develop, execute, and support FAI strategies including inspection activities and approvals.
• Support PPAP activities to ensure product and process conformance.
• Review and manage engineering and manufacturing changes, including change control documentation.
• Support equipment and process validation to ensure compliance with quality requirements.
• Review and maintain SOPs, risk management docs, and other quality records.
• Identify opportunities for process improvement, defect prevention, and quality performance.
• Apply quality engineering principles, risk-based approaches, and problem-solving methods to quality issues.
• Collaborate with cross-functional and multi-site teams to ensure regulatory compliance.
• Communicate quality requirements to stakeholders and promote a culture of quality.

Skills

Quality engineering

QMS

FAI

PPAP

Process validation

ISO 13485

GMP GDP

Risk management

Statistical methods

Documentation

Education

Bachelor's degree in Biomedical/Mechanical Engineering

Job description

Comrise is seeking a Quality Assurance Engineer in a medical device-oriented manufacturing environment located in New Jersey. The role emphasizes quality assurance, control, and continuous improvement to ensure product quality and regulatory compliance.

The ideal candidate will have hands-on experience with FAI, PPAP, change control, SOP maintenance, and risk management within ISO 13485/GMP/GDP frameworks, and will work both independently and with cross-functional teams to drive operational