Job Details

Description :

PRINCIPAL RESPONSIBILITIES:

• Ensure appropriate quality assurance strategies, regulatory strategies and sterilization strategies for the strategic manufacturing projects as determined by Global Operations are defined in co-operation with the strategic manufacturing leadership team and implemented.
• Stay abreast of quality management system changes, notifying the key stakeholders of changes that may impact the overall project timelines and update plans accordingly.
• Ensure compliance to Global quality management system requirements, Quality System Regulation (QSR), CMDCAS, ISO 13485:2003, European Medical Device Regulation and other Site Standards.
• Oversee the team to ensure that the QA, RA and SA aspects of the strategic projects are executed as per the project plan.
• Ensure that all critical to quality aspects of the product are clearly identified and remediation activities performed during project execution.
• Ensure that product quality is maintained or improved during project execution.
• Ensure that the product quality is stable and sustainable following the project execution.
• Establish quality metrics and implement statistical process control where applicable.
• Ensure effective communication and act as liaison and partner with on site and with business unit quality assurance operations, regulatory (internal and external), quality systems, sterility assurance, product development and sales & marketing personnel to ensure project success.
• Support due diligence activities in the assessment of manufacturing project requirements.
• Proactively manage people and team issues, actively resolves conflicts and build the organizational capabilities to deliver results now and into the future.
• Demonstrate initiative and critical thinking to resolve problems and work with the team to resolution.
• Exemplify Company Core Values that ensures a fair, open and productive climate.
• Attract, retain and develop people within the team.
• Ensure an ethical and legally compliant atmosphere.
• Provide other support requested by management
• Adhere to and ensure the compliance of Company’s Code of Ethics, all company policies, rules, procedures, and housekeeping standards.

Requirements :

• Microbiology, Biology, Medical Technology or Other Appropriate 4 Year Degree, MS Degree Preferred
• 15+ years’ experience in Quality Assurance, Regulatory Affairs and Sterility Assurance.
• Extensive knowledge and understanding of US and international medical device regulations, standards and guidance documents.
• Extensive knowledge and understanding of ISO13485, 21CFR820 quality management system requirements.
• Extensive Project Management skills and experience.
• People management skills and experience.
• Lean Six Sigma, CQE, CQA, ASQ certifications preferred