WINGLOBE
Location
Bangalore | India
Job description
Company Description Winglobe Healthcare Pvt.Ltd is a medical device company located in Bengaluru. The company manufactures innovative Advanced Energy Devices and Consumables with a focus on INNOVATION | QUALITY | CARE. They strive to provide quality products and services, while fulfilling the requirements across all surgical specialties, and positively impacting the outcomes for patients and their customers.
Role Description This is a full-time on-site role for a QA Lead. The QA Lead will be responsible for managing the overall Quality Control, Quality Assurance, Quality Management, and Good manufacturing Practice of the company's medical devices. Assisting for overall QA related activities. Plan and conduct internal audits & related record maintenance. Plan and face external audits for ISO 13485, CDSCO and CE. Supplier performance evaluation related record maintenance. Responsible for GDP & related record maintenance. Deliver training on the QMS to existing and new staff & maintaining training records. Issuing of QMS documents in the company as per documents / records control procedure & follow of change control procedure. Preparation and issue of SOP, WI etc. Active participant of Risk management activities of any new product development. Verification & Monitoring of QC reports, Production and batch manufacturing reports. Review of BMR & Label and batch releasing Customer complaint related record maintenance. Qualifications · Graduate / Post graduate in any science subject. · Min 2+ years of experience in medical device field, Knowledge on ISO 13485 is mandatory. · Exposure and knowledge of CE and CDSCO guideline is preferable (not mandatory) · Independent working experience · English communication and Writing skills. · Teamwork. · Detail oriented, ability to read various standards and guidelines & define implementation details. · Result oriented to develop and deliver components in a short span of time.Job tags
Salary
