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Job Title Sr. Quality Systems Engineer
Job Description If you are a Colorado resident and this role is a field-based or remote role, you may be eligible to receive additional information about the compensation and benefits for this role, which we will provide upon request. You may contact 888-367-7223, option 5, for assistance. In this role, you have the opportunity to Support post market activities and other quality tasks for the Sleep & Respiratory Care business unit with primary responsibilities in ensuring compliance in a fast-paced, changing global regulatory environment. The role includes development of strategies to act proactively where appropriate and reactively where necessary based on product performance in the field. The Sr. Quality Systems Engineer interfaces with all elements of the quality management system, Sleep & Respiratory Care business, global Philips businesses and markets, regulators, and notified bodies.The post-market surveillance team is responsible for monitoring, investigating, tracking and reporting on the performance of all Sleep & Respiratory Care products in the field. This activity is undertaken primarily through the management of the Complaint Handling System. The team is responsible for global vigilance reporting of individual events, field actions, communications with regulatory authorities and notified bodies, and creating the data required to make key decisions at the executive level to drive business critical decisions.You are responsible for- Complaint Handling in accordance with global regulations and standards
- Manage device field action and correction
- Drive the identification and investigation of critical product issues based on field data
- Design and implement compliant regulatory solutions supporting new paths to market
- Support post market activities related to new product introduction
- Team with a variety of roles such as Engineers, Scientists, Clinical Specialists, Field Service & Application Engineers, and Manufacturing personnel to facilitate post market surveillance processes globally
- Provide primary quality engineering support for global post market surveillance processes including complaint handling, vigilance reporting, field action, and post market surveillance planning activities
- Drive technical product investigations in support of field complaints, regulatory agency inquiries, CAPA, service actions, or other objectives and translate results for use in the quality management system.
- Consistently apply established device Risk Management File (RMF) decisions to investigations for both individual device failures and systemic failure modes. Identify and escalate issues not represented in established RMF.
- Ensure continued alignment of RMF with strategy for global vigilance reporting
- Coordinate development of strategy and implementation of field actions including risk assessment and plans for global vigilance reporting
- Drive execution of field actions on a global scale with responsibility to identify, assess, and overcome barriers to correction, keep current records, provide periodic status updates, and close field actions
- Team with Design Quality Engineering to ensure post market surveillance process capability is established for new product introductions
- Evaluate and apply regulatory guidance and changes to post market surveillance processes to ensure continued regulatory compliance
- Create responses to regulatory and customer inquiries
- Facilitate Post Market Clinical Follow-up activities
- Develop, implement, execute, and maintain post market surveillance plans for all products in partnership with Design Quality Engineering and Clinical Affairs
- Provide support to Corrective and Preventive Action (CAPA) device investigations and corrections.
- Support the internal audit program and participate in preparation and execution of internal and external audits of the local quality management system
- Enable a culture of continuous improvement by identifying individual opportunities for improvement and delivering results using LEAN concepts
- Lead continuous improvement projects driving cost savings and efficiency gains
- Develop and share best practices locally and with other Philips business partners
- Bachelor of Science in an engineering or applied science discipline
- Minimum 5 years' experience in the medical device or other regulated industry
- Demonstrated understanding of quality management system elements and interactions
- Experience with process improvement, six-sigma, lean manufacturing, or equivalent
- Experience with statistical analysis concepts and techniques
- Demonstrated success in project management, teaming and influencing others to achieve results
- Strongly preferred - Familiarity in quality complaint handling, vigilance reporting, field action, risk management, and detailed product investigation
- Applied knowledge and understanding of global medical device regulations
- Experience working with electromechanical devices; medical devices supporting respiratory and pulmonary clinical applications
- Experience teaming and interacting on a global scale
- ID: #20836174
- State: Pennsylvania Pittsburgh 15289 Pittsburgh USA
- City: Pittsburgh
- Salary: USD TBD TBD
- Job type: Permanent
- Showed: 2021-10-08
- Deadline: 2021-11-08
- Category: Systems/networking