Quality Engineer

Company: BEBIG Medical
Location: Mount Vernon
Posted on: July 29, 2022

Job Description:

This is a best chance to help save lives and provide affordable healthcare for everyone with your own expertise.We are now looking for candidate at below position for Mick Radio-Nuclear Instruments., Inc, our US Subsidiary of BEBIG Medical GmbH, a global supplier of radiation therapy medical device company. We have offices in Berlin, New York, Shanghai, Singapore and India with customers across more than 70 countries and regions.If you are interested in, please kindly send your CV to: hr@bebigmedical.comPosition: Clinical Application Specialist Main Tasks:--- Supports company goals and objectives, policies and procedures in compliance with the quality management system, FDA, Canadian, ISO and International regulation/requirements.--- Develop, execute and maintain technical documentation such as 510(k)'s, design history files (DHF's), device history and master records (DHR's/DMR's), IQ/OQ/PQ plans and protocols associated with product/process quality according to but not limited to FDA, Canadian, ISO regulations and company specific SOP's.--- Write up, review and revise qualification measurement system analysis (MSA's), Standard Operating Procedures (SOP's), Statistical Process Control (SPC's) and Failure Modes and Effects Analysis (FMEA).--- Provides quality engineering support to manufacturing and product development groups. Works closely with Operations and Engineering to develop and implement appropriate risk management, qualification, verification/validation plans.--- Assesses and provides recommendations for improvement of processes and equipment for compliance to cGMP and current ISO 13485 regulations within the Manufacturing, Quality & Regulatory processes to ensure safe and effective products are produced. Provides written reports and supporting documentation for recommendations.--- Reviews ECR's to ensure compliance to Quality Management System, FDA, Canadian, ISO and other International requirements (as needed) for new and current products.--- Supports the CAPA process, collaborating with owners to ensure effective root cause analysis and the development of innovative, long-term solutions.--- Tracks effectiveness of corrective action plans and compliance improvement initiatives.--- Ensures accurate project schedules are maintained and communicated to both internal and external management.--- Maintain Internal Audit and Calibration programs per FDA Part 820 and ISO 13485 standards.--- Responsible for performing and reporting on Supplier/Vendor Quality Audits.--- Carry out other reasonable tasks as required by the Chief Operating Officer.Requirements:--- Bachelor of Science (BS) degree in Biomedical or Mechanical Engineering - (other science based technical degrees will be considered) with a minimum of 7 years of Quality/Regulatory experience in the medical device/pharmaceutical industry, or--- MUST have thorough understanding of Current Good Manufacturing Practices, Quality Systems, Regulatory Requirements, Validation Principles and Manufacturing Methods in a Medical Device/Pharmaceutical regulated environment (demonstrated knowledge and application of quality system regulations - 21CFR820, MDD, ISO - 13485, ISO - 14971 and other international standards). --- Strong technical writing skills and ability to create technical protocols and reports as well as manufacturing inspection procedures.--- Understanding of inputs, outputs, raw materials, waste, quality control, costs, and techniques for maximizing the manufacture and distribution of goods.

Keywords: BEBIG Medical, Mount Vernon , Quality Engineer, Engineering , Mount Vernon, New York