<h2>Overview</h2> <p>The <strong>Production Quality Engineer</strong> is responsible for establishing, maintaining, and improving the quality systems and production quality processes required for compliant medical device manufacturing.</p> <p>This role is quality-focused first, with primary responsibility for ensuring compliance with ISO 13485 and FDA QMSR requirements, while also supporting hands-on problem solving within production operations.</p> <p>The ideal candidate is a practical, execution-oriented Quality Engineer who is comfortable working directly on the production floor, investigating issues, and driving them to resolution. While the role interfaces with manufacturing, engineering,<strong> and </strong>supply chain, the core expectation is strong ownership of quality engineering responsibilities.</p> <h2>Job Description</h2> <p><strong>Quality Systems & Regulatory Compliance (Primary Responsibility)</strong></p> <ul> <li>Develop, implement, and maintain quality system processes aligned with: <ul> <li>ISO 13485:2016</li> <li>FDA QMSR / 21 CFR Part 820</li> </ul> </li> <li>Author and maintain quality documentation, including: <ul> <li>SOPs</li> <li>Work instructions</li> <li>Forms and records</li> </ul> </li> <li>Support and maintain compliance of a predominantly electronic (paperless) QMS</li> <li>Ensure adherence to good documentation practices (GDP) and 21 CFR Part 11 (as applicable)</li> <li>Support annual FDA establishment registration and device listing activities; assist with preparation, maintenance, and coordination of regulatory submissions, including 510(k) support, technical file/design dossier support, and submission documentation coordination with Regulatory Affairs, as applicable</li> <li>Support internal audits and external audits (FDA, ISO certification, MDSAP readiness)</li> </ul> <p><strong>Nonconformance, CAPA & Issue Resolution</strong></p> <ul> <li>Investigate nonconforming product and process deviations</li> <li>Lead and support CAPA activities, including: <ul> <li>Root cause analysis (RCA)</li> <li>Corrective and preventive actions</li> <li>Effectiveness verification</li> </ul> </li> <li>Support complaint investigations and ensure feedback into manufacturing and process control</li> <li>Drive timely and complete resolution of quality events</li> </ul> <p><strong>Production Quality & </strong><strong>Hands-On Problem Solving</strong></p> <ul> <li>Work directly with production and technicians to: <ul> <li>Investigate product and process issues</li> <li>Identify sources of variation and failure modes</li> <li>Implement corrective actions</li> </ul> </li> <li>Ensure production processes meet defined quality requirements</li> <li>Support real-time decision-making on product disposition and quality concerns</li> <li>Identify and escalate risks to product quality or regulatory compliance</li> <li>This role requires a “get your hands dirty” mindset, including active engagement in troubleshooting and issue resolution on the production floor.</li> </ul> <p><strong>Process Validation & Control</strong></p> <ul> <li>Develop, execute, and maintain: <ul> <li>IQ/OQ/PQ validation activities</li> </ul> </li> <li>Support process changes and assess validation impact</li> <li>Ensure processes remain in a validated state</li> <li>Support development and maintenance of control plans and process monitoring methods</li> </ul> <p><strong>Risk Management</strong></p> <ul> <li>Support risk management activities aligned with ISO 14971</li> <li>Participate in: <ul> <li>Process FMEA (PFMEA)</li> <li>Risk assessment for manufacturing and process changes</li> </ul> </li> <li>Ensure risk-based decision making in quality and production activities</li> </ul> <p><strong>Supplier Quality (Supporting Role)</strong></p> <ul> <li>Support incoming inspection processes and acceptance criteria</li> <li>Assist in supplier issue investigations and corrective actions</li> <li>Collaborate with supply chain and engineering to ensure material quality</li> </ul> <p><strong>Cross-Functional Collaboration</strong></p> <ul> <li>Partner with: <ul> <li>Manufacturing</li> <li>Engineering</li> <li>Supply Chain</li> <li>Regulatory / Quality teams</li> </ul> </li> <li>Provide quality input on: <ul> <li>Design changes</li> <li>Manufacturing processes</li> <li>Product performance issues</li> </ul> </li> <li>Support design transfer and production readiness as needed</li> </ul> <p><strong>Supplier Quality & Material Control</strong></p> <ul> <li>Support <strong>supplier selection, qualification, and evaluation</strong></li> <li>Oversee <strong>incoming inspection and acceptance criteria</strong></li> <li>Participate in supplier audits and drive supplier corrective actions as needed</li> <li>Ensure material quality supports consistent production outcomes</li> </ul> <p><s