Specialist QMS

What will you do:

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.

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.