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Senior Quality Assurance Manager
2 weeks ago
A senior-level Quality Assurance Manager is sought by a pioneering medical device company to lead the development and implementation of its Quality Management System.
Key Responsibilities:- Lead cross-functional teams in developing, implementing, and maintaining quality processes that ensure compliance with regulatory requirements.
- Collaborate with internal stakeholders to develop and implement quality policies and procedures that drive business growth and improvement.
- Develop and manage audits to assess compliance with regulatory requirements and identify areas for process improvement.
- Ensure effective management of supplier performance through regular audits and assessments.
- Provide expert guidance on quality-related matters to support project development and tech transfer.
- Oversee the preparation and submission of regulatory documents and dossiers.
- 5+ years' experience in quality assurance within the medical device industry, ideally with Class II/III devices.
- Strong working knowledge of ISO 13485, FDA QSR, MDR, and relevant global regulatory frameworks.
- Experience with both internal and contract manufacturing environments.
- Demonstrated ability to build, maintain, and improve quality systems in a fast-paced setting.
- Practical, solution-oriented approach with excellent communication and collaboration skills.
- Degree in Engineering, Science, or a related technical field.
