Kalite Güvence Dokümantasyon Müdürü İş İlanı
İşveren Hakkında
QUALIFICATIONS AND JOB DESCRIPTION
Essential Responsibilities
- Responsible for ensuring quality and regulatory compliance in accordance with documented procedures for all aspects of functional responsibility.
- Performs audits as required to assure compliance with internal and external standards. Reviews and assures compliance with standards, specifications and other technical requirements.
- Supports continuous product and process improvement through detailed failure analysis for non-conformance, and investigates, develops and implements effective and compliant solutions for product or process corrections, retrospective and remediation action plans, and for corrective and preventive actions (CAPA Program).
- Communicate and work with sites and suppliers to determine root cause and corrective actions from both processing issues and supplier issues.
- Develops risk management tools and aids for use by the organization in accordance with documented procedures, including but not limited to Failure Mode. Analysis, etc. Develops process mitigation plans and strategies that are designed to mitigate the risks identified through the Risk Management process.
- Ensure an effective QMS system accordingly ISO 13485 and ISO 9001
- Lead, Direct, and coordinate activities concerned with the submission and approval of products to government regulatory agencies.
- Provide Quality Management System support – audits, review and update of regulatory SOPs, complaints, investigation, documentation review, approval and release, involve in government / regulatory audits and inspections and risk management.
Qualifications
- Bachelor’s degree in Engineering from an accredited university or college (or equivalent).
- Minimum 3 years of relevant Experience in internal and/or supplier audits, Good knowledge of medical device regulations (local regulations for the responsible countries and EU MDR), ISO 13485 and ISO9001,
- Having internal auditor certificate for ISO13485/ISO9001 would be an asset,
- Fluent in English (written and spoken)
- Proficient in MS Office (Excel, PowerPoint, and Word)
Other Skills And Attributes
· Thorough knowledge of FDA and International Regulatory requirements.
· Excellent organizational, interpersonal, written and oral communication skills required.
· In-depth working knowledge of quality and operations systems and processes.
· Proven success in the execution and application of quality systems, including the application of statistical principles, theories, and concepts.
- Outstanding commitment, being innovative and adaptive.
