Specialist QMS
Specialist QMS
Posted on :
05-04-2025
Employer Active
1 Vacancy
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Job Description
Work Flexibility: Hybrid
What will you do:
- 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 realtime 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 crossfunctional 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 BPharm / MPharm or related field from premier institutes
- 23 years of experience in Medical Device domain. At least 1 years of experience in training and Document controller.
Skills:
- Strong analytical and problemsolving 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 problemsolving skills. Proactive to support both internal and external customers.
Required Experience:
Unclear Seniority
Employment Type
Full-Time
Key Skills
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