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Ipg Photonics - Marlborough, MA

posted 2 months ago

Full-time
Marlborough, MA
Computer and Electronic Product Manufacturing

About the position

IPG Medical Corporation is focused on developing next-generation medical products based on its state-of-the-art technology. The Quality Management System Lead is responsible for the maintenance and continuous improvement of the quality management system (QMS) and compliance with all applicable regulations and standards for medical devices. This role is pivotal in ensuring that the quality system is not only maintained but also enhanced to meet the evolving needs of the organization and regulatory requirements. The Quality Management System Lead will work under the general direction of the Director of Quality, taking charge of reviewing, improving, and maintaining the quality system. This includes overseeing the Quality Manual, procedures/processes, training, and complaint handling. Key responsibilities encompass quality planning, vendor approval and monitoring, equipment calibration, complaint handling and trending, product recalls and advisory notices, corrective and preventive action systems, and conducting internal and supplier quality audits. The role also involves driving continuous improvement by monitoring processes and making recommendations for enhancements. In addition, the Quality Management System Lead will lead problem-solving teams through root cause investigations and failure analysis, ensuring that solutions are implemented and verified effectively. Building relationships across the business is essential for sharing knowledge, best practices, and solutions that can be leveraged across IPG Medical sites. The position also supports regulatory assurance, vigilance and incident reports, post-market surveillance, and risk analysis activities associated with the QMS processes, promoting a risk-based approach to quality management. Conducting internal audits of the quality system and supplier performance, preparing for and participating in audits by external organizations such as the FDA and ISO, and leading and developing direct reports are also critical components of this role. The Quality Management System Lead will perform other essential duties as assigned, contributing to the overall success of the quality management initiatives within the organization.

Responsibilities

  • Review, improve, and maintain the quality system including the Quality Manual, procedures/processes, training, and complaint handling.
  • Drive continuous improvement by monitoring and recommending enhancements to processes and procedures.
  • Lead problem-solving teams through root cause investigations and failure analysis to implementation and final verification.
  • Create relationships across the business to share knowledge, best practices, and solutions.
  • Assist with the implementation of Quality Management-approved solutions to ensure compliance with QMS processes.
  • Support regulatory assurance, vigilance/incident reports, and post-market surveillance as needed.
  • Conduct internal audits of the Quality System and Supplier.
  • Monitor supplier performance scorecard and manage supplier improvement activities.
  • Prepare for and participate in audits by external organizations, such as FDA and ISO.
  • Lead and develop direct reports.
  • Perform other essential duties as assigned.

Requirements

  • Bachelor's degree in business or science preferred.
  • 10-15 years of experience in Medical Device Quality Assurance, with 5 of the 10 years in hands-on management experience.
  • Experience using tools such as CAPA, Six Sigma methodology, change control, Statistical Analysis, and Control Plans.
  • Experience in stakeholder management and team leadership.
  • Solid understanding of applicable regulations, including FDA 21 CFR Part 820 and ISO 13485.
  • Understanding of Health Canada MDD's, European MDR's, MDSAP preferred.
  • Proven ability to support multiple projects and results-oriented.
  • Highly motivated and hands-on, with consistent ability to follow-through on projects.
  • Superior English language communications skills - written and verbal.
  • Ability to interact effectively with all levels of personnel within the organization and external customers.
  • Excellent organizational skills and attention to details.
  • Demonstrated ability to navigate through ambiguity and rapid growth, and adapt to change.

Nice-to-haves

  • Quality Auditor Certification
  • Knowledge of Medical Device start-ups is a plus
  • Six Sigma Experience / Certification
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