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A Global medical high-tech Company located in Shoham, is seeking a Quality Assurance and Regulatory Affairs Specialist with experience managing the development of medical devices through the approval process. The ideal candidate will have a strong regulatory and quality knowledge throughout product lifecycle with aspects of effective management and strategy.
Responsibilities & Scope of work:
Supports and maintains EU- MDR submission related activities (QMS, Technical Files, GSPR and PMS) and liaises with regulatory authorities
* Participation in internal and external audits e.g., FDA, Notified Body etc. for regulatory affairs matters - Oversight and performance of routine QA activities such as: ECO, MRB, NC, Monitoring of Calibrations, Training and Qualification, Customer Complaints, CAPA, Document and Record Control, Approval of qualification and validation activities etc.
* Control of processes in compliance with the applicable regulations and company procedure requirements - Participate in Management Reviews and analyze quality data
* Work closely with R&D through product development process and design activities.
* Support risk management activities including hazard analysis and FMEA. - Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
* Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance.
* Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents including the Medical Device Regulation (MDR), and all other standards/regulations included within applicable scope.
* Support and improve company Quality Systems by creating a quality culture and provide ongoing education on compliance activities.
* Contribute towards accomplishment of departmental and corporate goals and objectives
* All other duties as requested by his/her manager.

The Senior Specialist, Quality System Engineer will ensure the West IL Quality Management System consistently meets the regulatory, enterprise and customers requirements. The Senior Specialist, Quality System Engineer will be responsible for developing and implementing continuous monitoring and improvement of the Quality Management System according to applicable regulatory requirements- MDD 93/42/EEC, Medical Device Regulation (MDR) 2017/745, 21 CFR 820, MDSAP, ISO 14971, ISO 13485 etc. and will make sure the QMS is maintained and effective . Senior Specialist, Quality System Engineer will provide support with the analysis of quality issues to identify root causes and implement corrective action to reduce risk of quality failures.

Essential Duties and Responsibilities:
The Sr. Specialist, Quality System Engineer will have an in-depth knowledge and experience of the applicable regulatory requirements and will make sure those are implemented throughout the quality management system, maintain the quality system procedures by verifying their compliance to relevant regulatory requirements, lead quality related matter regarding MDR and other regulatory requirements.
Responsible for the sites internal audit program- managing the internal audit plan as per applicable regulatory requirements, lead audits, collaborate with additional auditors, maintain the pool of auditors, review and approve audit reports, set corrective actions and perform follow ups, as well as ensure nonconformances/deviations/complaints are investigated and assessed for root cause and identification and closure of effective CAPAs
Lead and perform risk-based approach (risk assessments) processes and implement control plans.
Responsible for site improvement projects related to Quality processes such as (but not limited to- Data integrity, Lean/Six Sigma projects, CoPQ/cost reduction, etc.).
Responsible for the QA approval of employees training files and approval of employees qualification certificates.
Responsible for the sites metrics and KPI data collection and analysis, including weekly, monthly (including MBR) and routine reports, both internally and externally. Collaborate with both internal and external stakeholders in relation to metric reporting. Identify trends in applicable areas, analyze, evaluate and initiate applicable actions to mitigate, and for presenting the data during Management Reviews
Responsible for the sites procedures alignment with applicable West Enterprise procedures.
Interact and collaborate with Laboratory; Operations, Engineering, R&D, RA, D&T and other functions to support resolution of Quality issues and investigations.
Maintaining the quality system procedures by verifying their compliance to relevant regulatory requirements.
Lead the activities to Identify and verify quality agreements with Economic Operators are up to date with the state of the art EU/US and ROW regulatory requirements along with references to the applicable SKU and distribution zones to the relevant customer/EO.

What you will be doing:
In the main role of Quality Complaints Specialist, you will be managing all routine activities for promoting and investigating customer complaints. Starting with registration and evaluating the reported events based on risk, all the way to investigations, implementation of action items, CAPA, ensuring reporting to authorities according to strict timelines and closure stage with all required evidence, including reports and analysis.
The role includes leading and participating in handling complaints weekly meetings, performing and providing data analysis, both in Word, PowerPoint or other formats, summarizing and capturing action items, and following up on their effective implementation until completion and closure.
You will take part in activities ensuring adherence to the Quality Management System, including improvement activities while assuring compliance is maintained.
Responsible for relevant procedures implementation.
Ensuring compliance with related regulatory requirements.
Getting and providing training in the relevant areas.
Supporting Global Objectives, Improvement projects and QA plans.
Reviewing and approving documentation. (such as procedures, protocols and reports).
Active participation in regulatory inspections (e.g. 21CFR820. ISO13485,MDD, CMDCAS, MDSAP, MDR), and other external and internal audits, including investigations and further CAPA/ corrections.
Supporting quality and company activities related with the job position and skills.