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Quality Engineer

Company: Synerfac Technical Staffing
Location: Buena
Posted on: April 5, 2021

Job Description:

Quality Engineer
Manufacturing Engineer

Our client located in South Jersey is currently looking for an Engineer to join their Quality Team. The company supports the Pharmaceutical industry and is rapidly growing and looking to fill multiple positions within the company. Please review the information below and if you feel you have the experience our client is looking for and would like to hear more about the opportunity please apply.

Operational Quality Improvement
* Execute pilot program activities directed by Quality Systems Manager supporting Operations Manager* Ensure compliance to program checklist activities and lead corrective actions for errors* Understand and communicate the performance and quality gains from strict adherence to best practices.* Collaborate cross-functionally to create necessary QMS documents (WIs, PMs, SOPs, Forms)* Ensure understanding and training to responsibilities within the plant Quality Department.

Quality Management System (QMS) Support
* Follow applicable requirements of FDA cGMP, ISO 13485, ISO 9001, ISO 14971, FDA 110/210/211, GFSI, Process Validation et. al.* Create, review, and approve validation IQ/OQ/PQ/PPQ protocols and reports.* Analyze and summarize data for validations, CAPA, and other quality initiatives* Internal Auditing of adherence to procedures* Manage the Visual Factory Layered Process Audit process and report out on deficiencies and actions* Monitor impact of plant-floor, process or setting changes on the validated state of the lines* Create, modify, and approve (with other SMEs) deviations and change control requests for documents, equipment, and processes* Track open deviations and change controls for proper closure and resolution.

Investigate Customer complaints, Non-Conformance Report (NCR), Corrective and Preventive Action (CAPA), and lead Continuous Improvement
* Use critical thinking and problem-solving skills to determine root causes of issues (5 Why, Fishbone, 8D, Is/Is-Not).* Lead and/or facilitate Operations and Quality cross-functional investigations. Determine corrections, corrective actions, and verification of effectiveness.* Analyze data and trends within the CAPA process to determine systemic risks.* Lead corrective action effort for systemic risks.* Document investigations and improvements using analysis of data (ANOVA, Cpk, Trending, etc.)* Identifying opportunities for Continuous Improvement, defining value and implementation.

Job Requirements WE ARE LOOKING FOR:
* Bachelor"s degree completed for technology, engineering, science or significant applicable experience, training, and certifications.* 2+ years" experience in Manufacturing or Quality Engineering.* Experience with Technical writing of reports, data analysis, customer response correspondence, and procedure manuals.

* Experience working in medical device or food manufacturing environments.* Experience with visual inspection standards and processes.* Experience with performing training for plant-floor personnel.* Experience with the validation of manufacturing and inspection processes.* Knowledge of the safety requirements and complexity of working with automated and semi-automated production and inspection systems in a factory environment.* Knowledge of vision inspection systems, and PLCs (programmable logic controllers for factory automation) preferred.* Knowledge of lean manufacturing principals in a high volume and high complexity environment.* Knowledge of injection molding and plastic assembly processes.

Keywords: Synerfac Technical Staffing, Camden , Quality Engineer, Engineering , Buena, New Jersey

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