Quality Assurance Manager
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We are seeking an accomplished Quality Assurance Manager to lead our quality assurance agenda, ensuring we meet customer requirements and regulatory compliance.
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* Lead the company-wide quality assurance agenda, ensuring compliance with relevant standards.
* Develop and maintain a quality management system, ensuring it is adequate for product quality control.
* Manage risk and design control activities, ensuring they align with ISO14971 and other international standards.
* Maintain ongoing maintenance, audits, and continuous improvement of the quality management system.
* Ensure regulatory clearance and maintenance for products in target markets.
* Implement home healthcare and electrical safety standards.
* Manage QA teams and promote best practice within the organization.
* Proactively manage processes to ensure product and service quality.
* Act as Management Representative for the Quality Management System.
* Manage the maintenance of the Quality System to ISO13485 and FDA requirements.
* Represent the quality department in all NPI/NPD activities.
* Complaints handling for medical reporting and filing to competent authorities.
* Regularly review and manage change control processes.
* Ensure products are cleared to appropriate markets according to Regulatory plans.
* Manage Regulatory Affairs support to internal and external customers.
* Keep the organization informed of changing regulatory and compliance requirements.
* Data collection and analysis for management reviews.
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Requirements
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* University Degree or Postgraduate qualification in Quality Assurance.
* 8+ years of experience in Medical Devices or similar regulated industries.
* Significant regulatory affairs experience, including international regulatory processes.
* In-depth knowledge of maintaining certified Quality Management Systems.
* Knowledge and application of Quality tools and methodologies.
* Trained QMS Internal Auditor.
* Awareness of quality assurance processes.
* High level of attention to detail.
* Proven leadership skills.
* Excellent verbal and written communication skills.
* Results-oriented and self-starter with ability to work on own initiative.
* Knowledge of and commitment to continuous improvement and problem-solving.
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