Quality Engineer Supervisor
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Description
PURPOSE OF JOB
Responsible for supervising and developing Quality Engineers while providing technical leadership for validation, continuous improvement, CAPA, nonconformance, and quality-system activities. The position ensures that quality engineering support is risk-based, timely, compliant, and aligned with business and customer requirements.
JOB OPERATION/ELEMENTS
Responsibilities
- Supervise Quality Engineers, assign priorities and workload, monitor deliverables, provide technical direction, and support timely completion of departmental objectives.
- Provide coaching, mentoring, and performance feedback to assigned engineers; identify development needs and promote technical growth, accountability, and succession readiness.
- Lead and/or support process, product, equipment, software, test-method, and product-transfer validation activities, including IQ, OQ, PQ, engineering studies, and revalidation, as applicable.
- Write, review, and approve validation plans, protocols, reports, statistical analyses, sampling rationales, deviations, and related documentation to ensure technical accuracy, traceability, and compliance with approved requirements.
- Lead or act as CAPA owner for assigned corrective and preventive actions, ensuring robust problem definition, containment, root-cause analysis, action implementation, effectiveness verification, and timely closure.
- Provide technical support and mentorship for CAPAs, NCMRs, deviations, out-of-tolerance events, complaints, and other quality investigations, promoting consistent use of root-cause and risk-analysis tools.
- Review and approve investigations and quality records, ensuring conclusions are supported by objective evidence and that product impact and regulatory risk are appropriately assessed.
- Lead continuous-improvement projects focused on reducing nonconformances, scrap, rework, cycle time, recurring quality events, and process variation.
- Use Lean Six Sigma, DMAIC, statistical methods, Poka-Yoke, Measurement System Analysis, process capability, and other appropriate tools to improve process performance and quality-system effectiveness.
- Partner with Manufacturing, Engineering, Operations, Regulatory, Document Control, and Corporate Quality to resolve technical issues and maintain alignment on priorities and quality requirements.
- Ensure manufacturing processes and quality-engineering activities comply with applicable quality-system procedures, ISO 13485, FDA Quality System Regulation requirements, customer requirements, and other applicable standards and regulations.
- Support internal, customer, and regulatory audits by preparing objective evidence, responding to technical questions, and supporting the development and completion of corrective actions.
- Develop and maintain procedures, work instructions, templates, and training materials needed to implement quality and validation requirements.
- Prepare and present project status, quality risks, investigation conclusions, validation results, and improvement outcomes to management and cross-functional teams.
- Promote a strong quality culture by reinforcing that quality ownership is shared across functions and by modeling ethical, compliant, and risk-based decision-making.
- Perform additional duties as assigned.
REQUIREMENTS
EDUCATION:
- Bachelor’s degree in Engineering or a related technical discipline is required.
- Working knowledge of ISO 13485 and applicable FDA quality-system requirements is required.
- ASQ CQE, CSSBB, Lean Six Sigma, or an equivalent quality certification is considered a plus.
- English proficiency at B2 level or higher is required.
EXPERIENCE:
- At least five years of experience in a medical-device or similarly regulated manufacturing environment is required.
- Experience with CAPA, nonconformance investigations, root-cause analysis, risk management, and continuous-improvement projects is required.
- Prior experience supervising, leading, mentoring, or providing technical direction to engineers is required.
- Experience with statistical analysis and Minitab or an equivalent statistical software package is required.