QA Engineer with Medical Device_2-4Years_Pune

Short Description

We are hiring QA Engineers with exp in Medical Devices for our Pune office.

Qualifications

BE/Btech/ME/Mtech/MCA

Job Responsibilities

Shall be responsible for process definition facilitation and implementation of Quality Management System as per ISO 13485 Support Proposal from Quality Assurance and Reglatory affaires requirements Should be able to conduct and handle external audits programs 3to5 years experience in Medical Devices Regulatory Affairs and Quality Assurance Qualified ISO 13485 Auditor along with awareness of various harmonized standards as ISO 14971 IEC 62304 IEC 62366 IEC 60601 Monitor impact of changing regulations on submission strategies and update internal stakeholders Develop new regulatory policies processes and SOPs and train key personnel on them Evaluate regulatory risks of processes procedures Provide regulatory input to product lifecycle planning as per multicountry regulatory Determine submission and approval requirements anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams Premarket Provide strategic input and technical guidance on regulatory requirements to development teams Assess the acceptability of quality and evaluate risk of product w r t Safety and performance Compile prepare review required technical documentation for regulatory submission Post Market Ensure compliance with product post marketing approval requirements Develop implement and manage appropriate SOPs and systems to track and manage productassociated events Oversee system to ensure that product safety issues and product associated events are addressed

Ref:

364172

Posted on:

November 6, 2019

Experience level:

Experienced

Contract type:

Permanent

Location:

Pune

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