Develop, implement, and maintain the QMS in alignment with ISO 13485:2016 standards. Create, review, and update QMS documentation, including quality policies, procedures, and work instructions.
Support during External (Notified Body for ISO 13485:2016) and Corporate Audits and Provide real-time support to the auditors by delivering requested documents, records, and evidence.
Maintain and update the Document Control System (Windchill) for controlled documents, including SOPs, work instructions, forms, and records.
Ensure document revisions, approvals, and distribution align with company policies and regulatory requirements (ISO 13485, FDA, EUMDR, etc.).
Coordinate with cross-functional teams to review and approve documentation.
Maintain the periodic review the documents.Maintain and update the Learning Management System (SLMS) with training records.
Track training completion rates and generate reports for management and audit purposes.Communicate training requirements to employees and provide reminders for upcoming deadlines.
Assist in evaluating training effectiveness through feedback collection and performance metrics.Support internal and external audits by providing training records and evidence of compliance.
What You Need:
Education and Experience:
BSC Biotechnology, B-Pharm / M-Pharm or related field from premier institutes
2-3 years of experience in Medical Device domain. At least 1+ years of experience in training and Document controller.
Skills:
Strong analytical and problem-solving skills.
Excellent written and verbal communication skills. Proficiency in QMS software and tools.
Nice to Have :
ISO 13485:2016 certification
Soft Skills
Excellent communication & interpersonal skills. High analytical skills.
Able to run communicate effectively with senior leadership. Excellent problem-solving skills. Proactive to support both internal and external customers.
