Quality Assurance Engineer

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

We are seeking a Quality Assurance Engineer to support quality assurance, quality control, and continuous improvement initiatives within an engineering and manufacturing environment. This role will focus on ensuring product quality, maintaining regulatory compliance, and implementing effective quality processes to support operational excellence.

The ideal candidate has experience in quality engineering, change management, and quality management systems, with the ability to work independently and collaborate with cross-functional teams.

Key Responsibilities

• Develop, execute, and support First Article Inspection (FAI) strategies, including inspection activities, documentation, and approvals.
• Support Production Part Approval Process (PPAP) activities to ensure product and process requirements are met.
• Review and manage engineering and manufacturing changes, including change control documentation and impact assessments.
• Support equipment and process validation activities to ensure compliance with established quality requirements.
• Review, revise, and maintain Standard Operating Procedures (SOPs), risk management documentation, and other quality records.
• Identify opportunities for process improvement, defect prevention, and enhanced quality performance.
• Apply quality engineering principles, risk-based approaches, and problem-solving methodologies to address quality issues.
• Partner with cross-functional and multi-site teams to ensure compliance with applicable quality standards, procedures, and regulatory requirements.
• Communicate quality requirements and provide guidance to stakeholders to promote a strong culture of quality and compliance.
• Maintain accurate documentation and support quality initiatives in accordance with established procedures and industry standards.

Qualifications

• Bachelor's degree in Biomedical Engineering, Mechanical Engineering, or a related technical field.
• At least 2 years of relevant industry experience in quality engineering, quality assurance, manufacturing engineering, or a related discipline.
• Knowledge of change management processes and Quality Management System (QMS) principles.
• Experience with First Article Inspection (FAI), Production Part Approval Process (PPAP), process validation, or engineering change control is highly desirable.
• Familiarity with medical device quality systems and industry concepts is preferred.
• Knowledge of ISO 13485, EU regulatory requirements, Good Documentation Practices (GDP), and Good Manufacturing Practices (GMP) is an advantage.
• Understanding of risk management, statistical concepts, and quality improvement methodologies is preferred.
• Strong analytical, problem-solving, and organizational skills with excellent attention to detail.
• Proficiency in Microsoft Office applications, particularly Word, Excel, and PowerPoint.
• Excellent written and verbal communication skills in English.
• Ability to work independently, manage multiple priorities, and thrive in a fast-paced environment.
• Strong interpersonal skills and the ability to build effective relationships with cross-functional stakeholders.

What We're Looking For

A proactive quality professional who can exercise sound judgment, take ownership of assigned projects, and advocate for quality across engineering and operational functions. The successful candidate will be comfortable working independently while collaborating with diverse teams to maintain compliance, improve processes, and ensure products meet established quality standards.