Quality Engineer Congers, NY

The Quality Engineer (QE) is primarily responsible for the design and execution of qualification & validation activities, leading the implementation of new or modification of existing manufacturing equipment/processes ( Injection Molding, Assembly), analytical testing equipment and/or facility related systems ( Cleanroom, process gases), in accordance with defined requirements, and customer expectations at the Congers, NY facility. The QE will bring a high-level quality mindset to validations and design transfer, ensuring these activities are thoroughly executed and properly documented in compliance with ISO 15378. The employee will also be involved in leading or supporting continuous improvement initiatives.

Primary Duties and Responsibilities: Responsible for leading and executing validation activities in a fast-paced cGMP manufacturing environment: review and approve executed qualification /validation documents, for facilities, processes, and equipment. Preparing of validation protocols/reports ( IQ, OQ, PQ), ensuring compliance and adherence to the design, customer and internal quality requirements, as applicable. Identify process and product quality non-conformances identified through the execution of validation activities Conduct, and/or participate in deviation investigations to identify root causes and define corrective/ preventative actions (CAPAs). Organize engineering runs and validation activities with cross-functional teams ( Production, Quality Control, Technical Operations) to meet project objectives. Lead training of cross-functional teams involved in validation related activities. Supports quality system, and manufacturing process improvement initiatives and analyze product performance to identify trends as necessary. Liaise with European design centers to ensure that design transfer and validation practices align with global requirements. Drive technical quality and validation activities to completion in accordance with project objectives/timelines, including organizing routine follow-ups during after execution to ensure compliance Supporting document creation, revisions, or reviews as needed Prepare customer communication for validation summaries, including deviation and CAPA summaries as needed. Support process and product improvement initiatives and analyze product performance to identify trends. Support customer complaint investigations, as needed Education: Bachelor's Degree or equivalent work experience in Engineering or other technical discipline Experience: 1 to5 years' of professional experience working in a regulated manufacturing environment (pharmaceutical / medical devices a plus); Experience data collection, data analysis, technical writing. Knowledge and experience with Root Cause Analysis (RCA), CAPA, Quality Risk Management, FMEAs and other key quality tools is a plus Knowledge of cGMPs, ISO 15378, 21CFR Part 11, Part 211 and/or 820 regulations is a plus Skills/Abilities: Strong problem solving and critical thinking skills Self-Starter with excellent written and communication skills. Able to work with a diverse cross-functional team with minimal supervision. Quality Engineering concepts such as statistical analysis, quality testing, sampling and inspection, process control is a plus Experience with Statistical Software ( Minitab) is a plus Travel; sometimes This role offers: An exciting, diverse and value based working environment. Award-winning corporate university offering personal development and training opportunities. Competitive base salary Contribute to the communities where we reside. Innovative benefits plan which includes 401k plan with Company matching benefit, paid time off, medical, dental, vision, life, disability and more