Quality Engineer (NY)

 

 

Summary

The Quality Engineer supports a chemical mixing / medical device manufacturing operation, ensuring compliance with applicable quality system regulations while providing direct shop-floor quality support. This role is responsible for complaints management, CAPA, change control, and supplier quality management, and works cross-functionally with Manufacturing, Engineering, Supply Chain, and Regulatory Affairs to drive product quality, process robustness, and continuous improvement.

 

In This Position, You Will Have the Opportunity To:

 

Shop Floor Quality

• Provide day-to-day quality support for operations
• Perform batch record review, deviations, nonconforming material investigations, and process troubleshooting
• Develop and implement test methods and procedures for inspecting, testing and evaluating product and processes

Complaints & Post-Market Surveillance

• Lead and/or participate in complaint investigations in accordance with FDA QSR, ISO 13485, and customer requirements
• Perform root cause analysis and ensure appropriate corrective and preventive actions
• Conduct trend analysis, escalation, and regulatory reporting (e.g., MDR support as applicable)
• Interface with customers regarding complaint investigations and responses when required

Corrective and Preventive Action (CAPA)

• Own and manage CAPA records, from initiation through effectiveness verification
• Apply structured problem-solving tools (e.g., 5-Why, Fishbone, FMEA)
• Monitor CAPA metrics, timeliness, and effectiveness to ensure sustained improvement
• Address CAPAs identified during internal and external audits

Change Control

• Participate in change control activities related to materials, suppliers, processes, equipment, and documentation
• Assess quality and regulatory impact of proposed changes, including risk evaluations
• Ensure changes are implemented in compliance with customer requirements and applicable regulations
• Assist with validation and verification activities as required

Supplier Quality Management

• Execute Supplier Quality initiatives and programs with activities such as supplier qualification, auditing, SCAR management, and PPAP
• Perform supplier qualification, monitoring, and performance management
• Review and approve supplier documentation (COAs, specifications, quality agreements)
• Participate in supplier audits, issue supplier corrective actions, and track resolution
• Maintain incoming inspection strategies and supplier risk assessments

Quality System & Compliance

• Ensure compliance with applicable regulations (FDA’s QMSR, ISO 13485, EUMDR, ISO 14971)
• Participate in internal, customer, and regulatory audits, including preparation and response activities
• Perform data analysis and reporting of quality metrics (scrap, rework, complaints, CAPA)

 

What You Need to Succeed in This Position

• Bachelor’s Degree in Engineering preferred, or a related technical discipline such as, Chemistry or Biology.
• A minimum of 3–5 years of quality engineering experience in a medical device, pharmaceutical, or regulated manufacturing environment.
• ASQ certification a plus (CQE, CQA)
• Experience in chemical mixing, liquid formulation, or filling operations preferred.
• Displays developed interpersonal skills: leadership, team orientation, ability to communicate at all levels
• Ability to make effective decisions and maintain effectiveness under changing circumstances and priorities
• Teamwork, communication, positive attitude required to support the manufacturing environment
• Problem Solving – able to perform root cause analysis and implement effective corrective actions  
• Able to effectively manage and complete multiple projects simultaneously
• Excellent computer skills including but not limited to Microsoft Office Suite

• Knowledge of quality systems including the quality manual, quality policy and applicable procedures and work instructions 
• Ability to support the establishment, implementation, and maintenance of the quality system in accordance to FDA Quality Management System Regulation, ISO 13485, and European Union Medical Device Directives.

 

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