Posted in: Other in Boston | Posted: |
Job Description
As a Senior Quality Management System (QMS) Engineer in the medical device sector, you will play a vital role in overseeing the development, implementation, and maintenance of our Quality Management System. This position requires a deep understanding of industry-specific regulations and standards such as ISO 13485, FDA 21 CFR Part 820, and the European MDR. Your expertise will be instrumental in ensuring our products consistently meet the highest quality and safety standards, thus maintaining our commitment to excellence in the healthcare industry. You will be accountable for supporting the continued development, improvement, and expansion of the Quality Management System and maintaining compliance with regulations, standards, and Corporate requirements. You will be responsible for providing collaborative support to quality system leadership. You will work with other organizational functions, including Operations, Quality, R&D, procurement, corporate functions, regulatory agencies, and suppliers.
Principal Responsibilities
Conduct management review meetings to evaluate the effectiveness of the QMS, presenting data-driven insights on quality performance, audit outcomes, and more to top management.
Provide strategic recommendations based on management review findings to drive continuous improvement and reporting of review outcomes to relevant stakeholders.
Act as the primary liaison for all external audits (customer, registrar, etc.) and FDA inspections, ensuring all necessary documentation and processes are readily available and in compliance.
Lead and execute comprehensive internal audits to assess compliance with QMS requirements, ensuring consistent adherence to internal standards and regulatory guidelines.
Address and resolve any non-conformities identified during external and internal audits, implementing corrective and preventive actions to enhance the QMS and maintain regulatory compliance.
Lead the initiation, investigation, and resolution of Corrective and Preventive Actions (CAPAs), ensuring thorough data analysis, RCA tools, and practical solutions to prevent recurrence while maintaining alignment with quality system and regulatory requirements.
Regularly update QMS documentation to reflect changes arising from CAPA investigations and ensure continuous compliance with evolving quality system standards and regulatory requirements.
Assist in drafting customer quality agreements and program manufacturing/ quality plans.
Oversee and manage unit-level quality processes using advanced Manufacturing Execution Systems (MES) like Factorylogix and Product Lifecycle Management (PLM) tools such as Siemens Teamcenter
Participates in Six Sigma improvement projects, including coaching and development of employees.
