Quality Engineer (Quality Assurance)

Quality Engineer (Quality Assurance)

Location

Mahwah, NJ (Hybrid – Minimum 3 Days Onsite)

Schedule

Monday – Friday | First Shift

Duration

12-Month Contract

Position Summary

We are seeking a Quality Engineer to support quality assurance, process validation, and compliance activities within a regulated manufacturing environment. This individual will work closely with manufacturing, engineering, and project teams to ensure processes, equipment, and products meet established quality and regulatory requirements.

The ideal candidate is a hands-on problem solver who can independently evaluate quality-related issues, support validation activities, and drive process improvements while maintaining compliance with quality management system requirements.

Responsibilities

• Support validation and qualification activities for new manufacturing equipment and processes.
• Review and execute validation protocols and related documentation.
• Develop, update, and maintain Standard Operating Procedures (SOPs), inspection plans, and quality documentation.
• Participate in change management activities and quality system processes.
• Support First Article Inspection (FAI) planning, execution, review, and approval.
• Collaborate with Manufacturing Engineering and project teams to establish effective process controls.
• Ensure compliance with quality standards, procedures, and regulatory requirements.
• Participate in risk assessments and implementation of preventive quality measures.
• Monitor project timelines and provide status updates to stakeholders.
• Work cross-functionally to resolve quality-related issues and support continuous improvement initiatives.
• Serve as a quality representative during project reviews and implementation activities.

Required Qualifications

• Bachelor's Degree in Engineering (Mechanical, Biomedical, Industrial, Manufacturing, or related field).
• Minimum 1 year of engineering or quality engineering experience in a manufacturing environment.
• Experience supporting validation, qualification, or process improvement activities.
• Strong problem-solving and analytical skills.
• Ability to make independent engineering decisions using sound technical judgment.
• Excellent written and verbal communication skills.
• Proficiency with Microsoft Office (Excel, Word, PowerPoint).
• Ability to manage multiple priorities in a fast-paced environment.

Preferred Qualifications

• Medical device industry experience.
• Familiarity with ISO 13485, GMP, GDP, or similar quality standards.
• Experience with equipment qualification and process validation (IQ/OQ/PQ).
• Experience with change control and Quality Management Systems (QMS).
• First Article Inspection (FAI) experience.
• Knowledge of risk management and statistical quality tools.
• Experience supporting product transfer or manufacturing implementation projects.

Success in the Role

First 30 Days

• Learn products, processes, and quality systems.
• Build relationships with key stakeholders and project team members.

First 60 Days

• Begin independently supporting validation and quality deliverables.
• Develop a strong understanding of manufacturing processes and project objectives.

First 90 Days

• Execute complex project tasks with minimal supervision.
• Provide quality guidance and communicate project status effectively across teams.

Why This Opportunity?

This role offers the chance to work on high-visibility manufacturing and product transfer initiatives while gaining exposure to validation, quality systems, process controls, and cross-functional engineering projects within a regulated environment.

Responsibilities

• Perform problem identification, resolution, loss reporting and continuous improvement
• Design and implement methods for process control, process improvement, testing and inspection
• Develop, execute, and analyze quality reporting measures
• Participate in internal and external quality audits

Qualifications

• Bachelor's degree or equivalent in Mechanical, Electrical, or Manufacturing Engineering
• 4 years' of industry experience
• Strong knowledge of quality tools used in the industry
• Analytical and quantitative approach to problem solving