Key Responsibilities:
• 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.
Qualifications & experience:
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.