Product Quality Engineer

<p><strong><span>Position Summary:</span></strong></p> <p>The Product Quality Team is a technical quality engineering team responsible for monitoring, understanding, and improving product performance, in addition to owning quality processes within the service organization.</p> <p>The Product Quality Engineer will be technical, hands-on, and customer-focused with an ability to analyze, diagnose and test product quality issues. The successful candidate is accountable, collaborative, has excellent communication and problem-solving skills, and is passionate about delivering world-class products that make healthcare more accessible, simpler, and safer.</p> <p>&nbsp;</p> <p><strong><span>Major Responsibilities:</span></strong></p> <ul> <li>Conduct hands-on analyses of returned products to identify root causes of failures</li> <li>Develop investigation criteria and test methods to properly diagnose and root cause field failures</li> <li>Analyze and trend on product performance data to provide recommendations for product improvements</li> <li>Perform Quality trending of Service data and conduct investigations to identify causes of Servicing and Service-related complaint trends, including issues in Servicing workmanship and Out of Box failures.</li> <li>Review the output of Servicing and related Complaint or Non-Conformance Investigation activities to ensure that the resulting work complies with all regulatory and service requirements, as well as facility, divisional, and corporate objectives for defect prevention and continuous improvement.</li> <li>Audit and review Complaint Investigations and records of Servicing activities to ensure they are thorough, accurate, self-explanatory, and completed in a timely manner into the complaint handling system.</li> <li>Analyze service-related PFMEAs and other activities to support pre-market and post-market risk management activities</li> <li>Provide ongoing training to Service staff on regulatory requirements associated with complaint investigations and Servicing records</li> <li>Foster supplier relationships and support Supplier corrective action requests</li> <li>Support Product Transfer teams by aligning quality requirements and processes for new or transferred products</li> <li>Plan, develop, and conduct Service Manual and Service work instruction validations (IQ, OQ, PQ), test method validations, and inspection method validations</li> <li>Participate in the development and review of engineering change orders that impact servicing activities</li> <li>Work with Engineering to design and implement tooling and fixturing required to perform servicing activities and implement error-proofing (Poke-Yoke) in those stations</li> <li>Work cross-functionally to support implementation of changes in servicing and inspection procedures to mitigate field failures.</li> <li>Support CAPAs, Escalations, DCNs, and other engineering projects to address and resolve field quality issues, ensuring timely implementation and compliance with quality standards</li> <li>Perform DHR, Service History record, and PFMEA reviews in support of complaint investigations</li> <li>Adhere to the letter and spirit of the company&rsquo;s Code of Conduct and all other company policies.</li> <li>While the above key responsibilities are the main elements of the titled job the Vice President Quality may at times request other tasks deemed to be within their capabilities.</li> </ul> <p>&nbsp;</p> <p><strong><span></span></strong></p> <p><strong><span></span></strong></p> <p><strong><span>Skills and Experience:</span></strong></p> <ul> <li>Excellent technical report writing skills</li> <li>Strong Root Cause Analysis, Design of Experiments, and test method development experience as related to Service activities and complaint or non-conformance investigations</li> <li>Experience in leading investigations and trending analysis, leveraging expertise in troubleshooting electro-mechanical systems and engineering custom test fixtures and apparatuses for functional and performance validation</li> <li>Ability to manage multiple investigations and projects independently.</li> <li>A solid understanding of the FDA QSR Quality System Requirements, and the ability to apply the knowledge to comply with goals and objectives.</li> <li>Strong experience with MS Office Products (Word, Excel, Visio, Project, PowerPoint, Outlook, etc.)</li> <li>Strong experience with statistical analysis of data. </li> <li>Experience with Minitab preferred. </li> <li>Experience with Six Sigma principles preferred.</li> <li>Excellent oral and written communication skills with the ability to communicate with audiences of varying technical skills</li> <li>A strong ability to prepare written technical plans and reports in support of engineering changes, product or process validations, and failure investigations.</li> <li>Strong focus on meeting customer needs.</li> <li>Ability to work with cross-functional teams.</li> <li>Ability to be self-driven and solve complex problems independently.</li> <li>Demonstrated strong attention to detail and &ldquo;do it right the first time&rdquo; attitude</li> </ul> <p>&nbsp;</p> <p><strong><span>Qualifications:</span></strong></p> <ul> <li>Bachelor&rsquo;s degree in an Engineering discipline (Electrical, Mechanical, Bio-Medical, etc.) or the equivalent work experience</li> <li>3-7 years of related hands-on engineering experience in the medical device industry, or equivalent.</li> <li>Ability to travel 10-20%</li> <li>Strong background in troubleshooting electro-mechanical systems and interpreting electrical schematics and circuit diagrams</li> <li>Experience using diagnostic tools such as digital multimeters and oscilloscopes, as well as developing and validating test methods for components including PCBs, motors, pumps, power supplies, and batteries</li> <li>Prior experience in implementing new processes and driving improvements.</li> <li>Experience in a customer focused Service organization is a plus</li> <li>Familiarity with ISO14971 and associated Risk Management Processes is a plus</li> <li>Knowledge of and/or experience with product decontamination and Blood Borne Pathogen exposure controls is a plus</li> <li>Experience in an FDA regulated environment is a plus</li> </ul> <p>&nbsp;</p>