Job Title: QA Associate
Job Description:
- Responsible for Implementing, controlling and monitoring quality management system documentation (ISO 27001) and data privacy (SOC2).
- Coordinate improvement in the system through output from audit, management review, and responsible to close NC’s during audits.
- Knowledge of SAMD (Software as Medical Device) SaaS product, processes and procedures.
3-5 years of relevant experience in Medical Devices Industry.
Area of Expertise:
- To generate, implement and maintain internal quality procedures and systems to comply with ISO 27001, SOC2 standards
- Maintaining and updating various documents like internal docs log, external log, , Obsolete docs log, DCN, ECN, CAPA, SQA/IQA log, product complaint, equipment log
- Maintaining Engineering documents like part specs, Bill of materials, Drawings, Design review documents etc
- Co-ordinate and conduct periodic internal audits of various functional groups of an organization and drive compliance to QMS.
- Manage all documentation related to internal and external audit.
- Manage all the documents related to supplier qualification and coordinate Supplier’s audit and maintain the supplier file.
- Experience in Handling of CAPA (Corrective & Preventive Actions) & Product Complaints
- Co-ordination of Management Review Meetings & its action items implementation
Experience Required:
- 3-5 years of relevant experience in Medical Devices Industry.
- Educational Qualification – Diploma/Engineering graduate, preferably Computer Science or related.
- Ability to read and understand standard requirements independently.
- Good teamwork, communication and interpersonal skills. A demonstrated commitment to company values
- Good understanding of design control, and post marketing processes
- Knowledge of FDA / EU / Indian & other national regulations is an added advantage.
- Working knowledge of an e-QMS is an added advantage.
Shubham Vishwakarma
Full Stack Developer - Averlon
About Synapsica Technologies Pvt Ltd
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