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Senior Manager, Quality Assurance
1 month ago
We are seeking a highly skilled and experienced Senior Manager, Quality Assurance to support our Manufacturing Quality team. This role is critical in ensuring that our products meet the highest standards of quality and compliance.
The ideal candidate will have a strong background in quality management within the medical device industry and a proven track record of leading quality initiatives in a manufacturing environment.
Key Responsibilities:
- Lead and manage the Manufacturing Quality team to ensure compliance with all regulatory requirements and company standards.
- Develop, implement, and maintain quality systems and processes to support manufacturing operations.
- Oversee the investigation and resolution of quality issues, including root cause analysis and corrective/preventive actions.
- Collaborate with cross-functional teams, including R&D, Engineering, and Operations, to ensure quality is integrated into all aspects of product development and manufacturing.
- Conduct regular audits and inspections of manufacturing processes to ensure adherence to quality standards.
- Provide leadership and guidance on quality-related matters to ensure continuous improvement and operational excellence.
- Prepare and present quality reports and metrics to senior management.
- Stay current with industry trends and regulatory changes to ensure compliance and best practices.
- Ensure compliance with clean room standards and protocols, including monitoring and maintaining clean room environments.
Requirements:
- Bachelor's degree in Engineering, Life Sciences, or a related field; advanced degree preferred.
- Minimum of 8-10 years of experience in quality management within the medical device industry.
- Strong knowledge of FDA regulations, ISO standards, and other relevant quality standards.
- Proven experience in leading and managing quality teams in a manufacturing environment.
- Excellent problem-solving skills and the ability to make data-driven decisions.
- Strong communication and interpersonal skills, with the ability to work effectively with cross-functional teams.
- Certification in quality management (e.g., ASQ CQE, CQA) is a plus.
- Experience with clean room environments and maintaining clean room standards.
