Quality Engineer - Validation & Compliance

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 #J-18808-Ljbffr Comrise