Overview
Quality Engineer (Quality Assurance) Jobs in Mahwah, NJ at Comrise
Title: Quality Engineer (Quality Assurance)
Company: Comrise
Location: Mahwah, NJ
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
