Qualifications :
- BS / MS in Engineering or Life Science
- Minimum three (3) years of active senior quality management and leadership experience; and minimum ten (10) years related experience in an FDA regulated environment
- ISO 13485 – Lead Assessor Certification
- ASQ and RAPS Certifications are a plus (e.g., Quality Engineer, Certified Quality Manager)
- Demonstrated knowledge of interpretation and application of QSR, EU MDR, ISO 13485, and other applicable regulations and standards
- Experience in design, manufacturing, or technical support for medical devices or other technically complex or regulated products
- Working knowledge of basic assembly and manufacturing processes
Responsibilities :
- Provide project teams with the guidance necessary to maintain a high level of QMS compliance
- Ensure that project quality planning is consistent with project objectives and delivers a Quality Management Responsibilities Plan for individual projects as needed
- Ensure that project quality activities are efficient and effective and performed in a proactive manner
- Oversee the generation and maintenance of quality records that are consistent with Company’s QMS
- Develop SOPs, work instructions, guidance documents and templates to drive compliance and to facilitate dissemination of best practices related to quality management systems
- Support QMS related training and professional development for scientific and technical staff
- Own the Quarterly Management Review process, managing and reporting project and operational quality metrics to management
- Provide input to quality-related strategic planning to meet short and long term business goals
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