Qureos Mentor

SaniSure

<div>Job Summary
The Supplier Quality Engineer (SQE) is responsible for ensuring that externally sourced materials, components, and services meet applicable regulatory, quality, and performance requirements for medical device manufacturing. This role partners cross-functionally with Supply Chain, Manufacturing, R&amp;D, and Regulatory Affairs to qualify, monitor, and continuously improve supplier performance in compliance with FDA 21 CFR Part 820 (QMSR), ISO 13485, and other global regulatory standards.
Essential Functions<ul><li>
Supplier Qualification and Onboarding<ul><li>
Lead supplier selection and qualification activities, including:<ul><li>
Supplier audits (on-site and remote)</li><li>
Quality system assessments</li><li>
Technical capability evaluations</li></ul></li><li>
Approve supplier validation documentation and quality agreements</li><li>
Establish supplier quality requirements and acceptance criteria</li><li>
Ensure suppliers meet ISO 13485 and FDA QSR/QMSR expectations<ul><li>
Supplier Auditing and Oversight o Plan and execute supplier audits in accordance with risk-based audit schedules</li></ul></li><li>
Evaluate compliance to:<ul><li>
21 CFR Part 820</li><li>
ISO 13485</li><li>
ISO 14971 (as applicable)</li><li>
ISO 11135 / 11137 (for sterilization suppliers, if applicable)</li></ul></li><li>
Document audit findings and drive timely corrective actions</li><li>
Assess supplier readiness for regulatory inspections<ul><li>
Supplier Performance Monitoring</li></ul></li><li>
Establish and maintain supplier scorecards and KPIs</li><li>
Analyze supplier quality trends (PPM, NCRs, SCARs, OTD, etc.)</li><li>
Drive continuous improvement initiatives with suppliers</li><li>
Conduct quarterly business reviews as needed<ul><li>
Nonconformance &amp;CAPA Management</li></ul></li><li>
Lead supplier corrective action requests (SCARs)</li><li>
Investigate supplier-related nonconformances and complaints</li><li>
Perform root cause analysis (5-Why, Fishbone, etc.)</li><li>
Verify effectiveness of corrective and preventive actions</li><li>
Escalate critical quality issues appropriately</li><li>
Validation and Change Management Support</li><li>
Support supplier-related validation activities, including:<ul><li>
Process validation (IQ/OQ/PQ)</li><li>
Sterilization validation oversight</li><li>
Packaging validation support</li></ul></li><li>
Review and approve supplier change notifications</li><li>
Perform risk assessments for supplier changes</li><li>
Ensure proper implementation through change control processes</li><li>
Ensure compliance with biocompatibility, material, and regulatory requirements</li><li>
Support regulatory submissions requiring supplier documentation<ul><li>
Risk Management</li></ul></li><li>
Participate in supplier risk assessments</li><li>
Support DFMEA/PFMEA related to supplied components</li><li>
Ensure critical suppliers are identified and controlled appropriately<ul><li>
Cross-Functional Collaboration</li></ul></li><li>
Partner with:<ul><li>
Engineering during new product development</li><li>
Operations during scale-up and product transfer</li></ul></li><li>
Provide supplier quality input during design reviews</li></ul></li><li>
Perform additional job duties as assigned.</li></ul>
Education<ul><li>
Bachelor&rsquo;s degree in biological sciences, engineering, or a related field.</li></ul>
Required Experience &amp; Competencies<ul><li>
Minimum 5 years of quality experience in a regulated industry</li><li>
Strong knowledge of: FDA 21 CFR Part 820 (QMSR), ISO 13485, Risk Management (ISO 14971), CAPA systems, Supplier auditing practices</li><li>
Experience conducting supplier audits independently</li><li>
Experience managing SCARs and supplier performance metrics</li><li>
Strong technical writing and analytical skills</li><li>
ASQ Auditor, Lead auditor certification for 13485 preferred</li></ul></div>

Supplier Quality Engineer

<div>Job Summary
The Material Handling and Inventory Control Manager oversees the movement, control, and staging of raw materials, components, and finished goods. This role ensures inventory accuracy, efficient material flow, and alignment with production schedules. The manager leads a team of material handlers and cycle counters, and collaborates cross-functionally with manufacturing, quality, procurement, and logistics to support operational goals.
Essential Functions<ul><li>
Manage daily operations of material handling, inventory control, and kitting.</li><li>
Coordinate with production planners and production leadership to prioritize kitting based on job orders and production schedules.</li><li>
Track and report material shortages or discrepancies; lead root cause investigations and corrective actions.</li><li>
Maintainaccurateinventory records and ensure ERP system data integrity.</li><li>
Enforce 5S/workplace organization standards within material handling and kitting areas.</li><li>
Lead and develop team members, ensuring compliance with cGMP, OSHA, ISO 9001, and PPE protocols.</li><li>
Support cycle counts, physical inventory audits, and reconciliation activities.</li><li>
Prepare and present inventory metrics and reports to management.</li><li>
Approve timekeeping records and manage staffing to meet operational needs.</li><li>
Support audits, compliance initiatives, and continuous improvement efforts.</li><li>
Perform other duties as assigned.</li></ul>
Education<ul><li>
Bachelor&rsquo;s degree in supply chain, operations, or related field preferred; equivalent experience considered.</li><li>
APICS, CPIM or similarinventory managementcertificationpreferred.</li></ul>
Required Skills &amp; Experience<ul><li>
5+ years in inventory control, materials management, or warehouse operations, including 2+ years in aSupervisory/Managementrole.</li><li>
Experience in manufacturing or biopharma environments preferred.</li><li>
Expertise ininventory control methods (e.g., cycle counting, FIFO/LIFO, Kanban) and warehouse best practices.</li><li>
Strong working knowledge with lean manufacturing, 5S, or Six Sigma principles.</li><li>
Proficient in ERP/WMS systems (e.g., SAP, Oracle, NetSuite); Syteline preferred.</li><li>
Skilledin team leadership, performance management, and conflict resolution.</li><li>
Excellent organizational, problem-solving, and communication skills.</li><li>
Ability to manage multiple priorities and meet deadlines in a fast-paced, regulated environment.</li><li>
Proactive and data-driven, metric-based approach to decision-making and process improvement.</li></ul></div>

Material Handling & Inventory Control Manager

Join SaniSure and explore 2   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.

SaniSure

About Company

Supplier Quality Engineer

Material Handling & Inventory Control Manager