Specialist Quality
Specialist Quality
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Job Description
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 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.
Qualifications & experience:
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
