מדעים/ביוטק

Quality Assurance and Regulatory Engineer

346705

תאריך עדכון

24/09/2020

תיאור המשרה

The QA and RA Engineer is responsible for the planning and execution of quality assurance activities ensuring that processes, products and services meet all external and internal quality requirements and are in compliance with regulations. 

QA & RA Engineer supports management and team in all aspects of the Quality Management System (QMS) to: 

• Facilitate quality minded company culture

• Ensure that regulatory, statutory and customer requirements are met for processes and products

• Identify and follow up on correction of product nonconformance and process noncompliance situations

• Identify and implement opportunities for improvement to product and processes

This position interacts with all functions and levels throughout the company and outside the company. Internally, the QA & RA Engineer works closely with R&D and Production to plan, execute, and monitor compliance with QMS. Externally, the QA & RA Engineer interacts frequently with sub-contractors and suppliers when qualifying, auditing and overseeing their work. In addition, the Quality Manager interacts with regulatory agencies that are responsible for auditing the company’s quality system.

This is a key position in maintaining and improving the quality system of a company that its leading device will improve dramatically the quality life of many people around the world. 

RESPONSIBILITIES:

• Assist with development, deployment, and execution of Quality Policies, Quality Objectives, and Quality Plans

• Directly responsible for QMS activities including QA Training, Internal Audits, CAPA Process, Complaints, Change Control, and Document Control.

• Responsible for implementation, support, and maintenance of computer systems used for QMS processes

• Support the development and implementation of all QMS processes and procedures across company, including but not limited to; Design and Development, Risk Management, Purchasing & Supplier Quality, Process Control, Identification and Traceability, and Servicing

• Monitor and audit the QMS processes for compliance, effectiveness, continued alignment with applicable regulatory and statutory requirements, and opportunities for improvement

• Collect, analyze, and present data on the QMS status during Quality and Management Review Meetings

• Representative for audits from external regulatory authorities and registration agencies

• Responsible for supplier qualification and audits with emphasis on mechanically challenging processes

• Responsible for ensuring equipment is calibrated and maintained on schedule

• Determine, implement, and monitor environmental conditions for production and warehouse facilities (including ESD program)

• Review DHR and perform Lot release

• Serve as a quality lead in project core teams

REQUIREMENTS

• Engineering or Bachelor’s degree, preferably in an applicable technical discipline, formal education in Quality – an advantage

• 5 years of experience in Quality Assurance in medical device development and manufacturing environment, including exposure to FDA/ISO regulations (and standards such as ISO 13485, ISO 14971, 21 CFR 820/211, and MDD/MDR)

• Must have experience in developing, implementing, and maintaining effective Quality System Processes

• Must have specific experience in auditing. Lead auditor/qualification as an internal auditor – an advantage

• Experience in writing procedures, creating management level presentations and reports

• Experience with Process validations (IQ/OQ/PQ), Test methods validations (TMV), design verification test methods development

• Experience with Root cause analysis of manufacturing failures and statistical analysis of manufacturing failures and NCRs (non-conforming materials)

• Must be proficient in the use of Microsoft Office applications

• Prior hands-on experience with QA for manufacturing – an advantage

• Prior experience with root cause analysis, Statistics, Lean Manufacturing, and Six Sigma – an advantage

• Prior experience with international companies -an advantage

• Ability to lead and influence others indirectly

• Assertiveness – capable of promoting changes

• Organized and methodic 

• Detail oriented

• Strong interpersonal skills and ability to work in multi-disciplinary teams

• Strong verbal and written communication skills in English- mother tongue level

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