RA QA Specialist

Overview:

·      The QA/RA Project Manager is part of the LDP Consulting Team that provides support to companies, which develop, design, manufacture and distribute medical devices. The QA/RA Project Manager will be responsible for Quality Assurance, Regulatory Affairs and Project Management activities.  

Job Description:

·      Support and guide the customer in different activities related to the company’s Quality Management System (QMS) and the medical device, according to the project’s scope and needs.  

·      Responsible for defining and meeting the project’s timelines and report its status from time to time.

·      Responsible for establishment, maintenance and management of the customer’s QMS and document control according to applicable regulatory requirements.

·      Coordinate and document internal processes, such as: employees training and qualifications, internal audits, Corrective and Preventive Actions (CAPAs) and Management Reviews.

·      Responsible for approval and monitoring of the customer’s suppliers and sub-contractors.

·      Lead and/or support the R&D Team in design control activities and related processes such as: Verification and Validation (V&V) testing, risk management and change control. 

·      Lead and/or support the Production Team in development and maintenance of the Device Mater Record (DMR).

·      Implementation of applicable new or revised regulatory requirements within the company’s QMS and communicating the gaps and implementation plan to relevant personnel.

·      Assist in compiling and preparing materials for submission to regulatory authorities.

·      Lead and/or participate in external regulatory audits and promote audit readiness within the company.

Required Background:

·      3-5 years previous experience in the QA and/or RA fields in the medical device industry - advantages to SW and HW companies.

·      Relevant University/Professional background.