The Quality Engineer will support the quality, reliability, and compliance of Transonic’s ISO 13485 Quality Management System and medical device products. The primary focus of this position is leadership of the Company's Nonconforming Material Report (NCMR) process, including coordination of failure investigations, disposition of nonconforming materials, Engineering Change Order (ECO) scoping, quality standards and regulatory monitoring, and support of key Quality Assurance processes.
This position is responsible for ensuring nonconforming materials and products are properly documented, investigated, evaluated, dispositioned through the appropriate review process, and closed in a timely manner while supporting applicable Quality System and regulatory requirements. The Quality Engineer will work cross-functionally with Quality Assurance, Regulatory Affairs, Engineering, Manufacturing Engineering, Manufacturing, Planning, Repair, and other internal teams to support failure investigations, root cause analysis, ECO scoping, audit readiness, and continuous improvement initiatives.
Duties and Responsibilities
NCMR Process Owner
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Serve as the primary Quality representative and process owner for the company’s NCMR program.
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Provide guidance on Quality System requirements, investigation expectations, risk evaluation, disposition decisions, documentation, and timely closure.
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Lead and coordinate cross-functional failure investigations involving nonconforming materials, components, assemblies, and finished products.
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Ensure nonconforming materials are appropriately identified, contained, evaluated, dispositioned, and documented.
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Facilitate daily cross-functional NCMR review meetings to:
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Prioritize newly opened NCMRs.
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Review investigation and disposition status.
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Address overdue actions and unresolved barriers.
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Assign and coordinate follow-up activities.
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Drive timely and effective closure.
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Work closely with Manufacturing, Engineering, Manufacturing Engineering, Planning, Repair, Quality Assurance, and other stakeholders to obtain the information needed to support investigation and disposition decisions.
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Ensure NCMR records are complete, accurate, appropriately approved, and maintained in accordance with applicable Quality System and regulatory requirements.
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Support root cause analysis and ensure investigation conclusions are supported by appropriate evidence and documented rationale.
Quality Data, Trending, and Reporting
- Analyze NCMR, failure investigation, deviation, and related quality data to identify trends, recurring issues, and emerging risks.
- Recommend opportunities for corrective action, preventive action, process improvement, supplier follow-up, or CAPA initiation.
- Develop and maintain meaningful NCMR metrics and key performance indicators.
- Prepare and present Management Review information related to NCMRs, failure investigations, deviations, ECO activities, and other assigned Quality System processes.
- Communicate significant trends, risks, and recurring quality issues to Quality leadership and appropriate process owners.
Additional Quality System Support
- Support the monitoring and review of applicable standards and regulatory requirements, including ISO 13485, FDA requirements, EU MDR, MDSAP, and other applicable Quality System expectations.
- Communicate relevant standards or regulatory updates to Quality, Regulatory Affairs, Engineering, Manufacturing, and leadership teams.
- Assist in evaluating the potential impact of new or revised standards and regulatory expectations on Quality System procedures, records, processes, and product-related activities.
- Provide backup support for ECO activities, including:
- Technical and quality review.
- ECO scoping.
- Documentation follow-up.
- Implementation task tracking.
- Verification of completion and closure.
- Provide backup support for the deviation process, including documentation, routing, impact assessment, review follow-up, action tracking, and closure.
- Help ensure deviations are appropriately justified, reviewed, approved, implemented, and closed in accordance with Quality System requirements.
- Support the company’s Safety Data Sheet program, including maintaining applicable records within the Quality Management System.
- Support CAPA activities associated with NCMRs, including investigation, root cause analysis, implementation of corrective actions, and effectiveness verification.
- Participate in internal and external audits by supporting audit preparation, record review, auditor requests, audit responses, and follow-up activities.
- Support minor internal audits, including audit planning, execution, documentation of results, identification of observations or opportunities for improvement, and corrective action follow-up.
- Identify Quality System gaps and support continuous improvement initiatives that strengthen compliance, documentation, process effectiveness, and operational performance.
- Provide additional Quality Assurance support as assigned by management.