Clinical Research Associate

Job Title: QA Associate 

Job Description:

1. Responsible for Implementing, controlling and monitoring quality management system documentation (ISO 27001) and data privacy (SOC2).
2. Coordinate improvement in the system through output from audit, management review, and responsible to close NC’s during audits.
3. 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.

Role and Skill of Physiotherapy

• Willingness to work for a Home Care environment.
• Need to focus on restoring physical function.
• Need to be sensitive to the patients' needs and disabilities and must have excellent communication and motivational skills.
• Create positive impact in the prevention of subsequent acute events and support the individual’s ability to live independently through targeted interventions aimed at improving balance, strength, coordination and function.
• Should personally also be physically fit enough to properly demonstrate the activities in their treatment plans and must possess strong organizational skills.
• Should possess either of the areas of expertise: pain management, sports injury management, paediatric therapy, post-operative therapy, arthritis management, neuro or posture correction.
• The conditions to be treated are back pain, neck pain, shoulder pain, knee pain, arthritic pain, slipped disc and any other kind of sprains.
• Creating an impact on overall patient experience by
  • Targeting the recovery of physical function of stroke patients through low risk activities resulting in high patient satisfaction.
  • Providing a service which reduces the risk for poor health outcomes, increases daily living and personal activity.