Quality Engineer (NY)

Talent Acquisition Team•New York, NY

About The Position

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.

Requirements

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.
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.

Nice To Haves

ASQ certification a plus (CQE, CQA)
Experience in chemical mixing, liquid formulation, or filling operations preferred.

Responsibilities

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)