Job Description

　　Insight Global is looking for two Sr. Quality Engineers to support one of our large Medical Device manufacturing clients in Rochester, NY. This position will be responsible for supporting the quality system structure (DHR, process control plan, PFMEA, participate in design control activities, etc.) of the process and product alignment. They will be responsible for managing quality related problem solving and continuous improvement opportunities for contact lens manufacturing. This position will be an integral part in leveraging the process and applicable design transfer activities to bring a new product to market by creation /review of statistical sampling plans, managing root cause investigation teams, evaluating data using statistical tools, and developing corrective action plans. The main responsibilities will be writing, reviewing, and approving protocols for qualification activities. Said revisions and updates will take place on already existing products and procedures.

　　Primary Responsibilities:

　　Lead / Support Change Control to manage business needs and continuous improvement activities

　　Provide guidance and approvals of applicable validations and change control documentation

　　Manage NC/CAPA through identification and development of corrective action plans through closure

　　Provide technical support to production in defining and resolving problems

　　Lead and Participate in Risk Analysis activities

　　Identifying opportunities for continuous improvement

　　Ownership of the process control plan and its implementation

　　Skills and Requirements

　　Bachelor's Degree in science or related field

　　8+ Years of relevant experience in Quality Engineering in Medical Device

　　Experience with process validation, IQ, OQ, PQ, FMEA, Change Controls, DHF, Risk Management

　　Strong statistical analysis, knowledge of sampling plans and root cause investigative skills * Six Sigma Black or Green Belt certification

　　Design control experience null

　　We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion,sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to [email protected].