Ibrahim Elayan
Memphis,TN
Summary
Dedicated and results-driven Quality Engineer with a proven track record in Supplier Development, Compliance, production, and Process Improvement. ISO 13485 and ISO 9001 certified Lead Auditor with experience in managing global suppliers, implementing Lean projects, and supporting regulatory compliances. Strong background in production quality engineering, non-conformance management, CAPA and Supplier Quality.
Overview
7
7
years of professional experience
1
1
Certification
Work History
Assoc. Quality Manager
Highridge Medical -Previously known as ZimVie
06.2024 - Current
- Manage the EU MDR contractors over the GMED EU MDR submission
- Develop and maintain relationships with Strategic Alliance Partners
- Lead recall activities related to Strategic Alliance partners
- Manage the Manufacturing transfer project of product, services, and operations from an external supplier site to another external supplier
- Manage and approve Supplier Quality related activities such as, quarterly qualifications, SCARs, PPAPs, SCNs, and CMLs
- Oversee the Supplier Quality related metrics such as KPI’s, scorecard, lot acceptance rate, and combined supplier quality score
- Ensuring monthly/quarterly metrics are on time, meet our internal requirements and drive continuous improvement
- Approval of Vendor Request Forms for the sourcing team and coordinate the supplier’s addition to the ASL
- Global Harmonization Project Management, ensuring a seamless transition from a corporate QMS to a standalone global system, with a focus on supplier-related modules following the spin-off
- Disposition of supplier caused non-conformances ensuring corrective and preventative actions are initiated from the supplier site.
Sr. Supplier Quality Engineer
ZimVie -Previously known as Zimmer Biomet Spine
01.2022 - 06.2024
- Proactively engaged in advancing Supplier Development, overseeing deliverables, control plans, and performance monitoring
- Analyzed and tracked site-wide Supplier-related defects to ensure compliance and foster continuous improvement
- Calculated and presented monthly supplier Lot Acceptance Rate and KPI to upper leadership
- Lead SQE over the transfer of tissue products from an external distributor to our internal distribution site
- Planned and executed quarterly supplier qualifications
- SME and process owner for Supplier Corrective Action Reports (SCARs)
- Co-lead external medical device and tissue suppliers audits as part of the requalification process
- Conducted internal audits for ZimVie Distribution Controls Quality Management System
- Lead Internal Auditor for the Design and Development process, ensuring compliance with MDSAP Chapter 5 and identifying any process gaps
- Led the audit backroom for multiple notified body audits, including BSI, MDSAP, and GMED
- Served as the SQE responsible for Level 1 subcontractors, distribution, sterile packaging, and tissue suppliers.
- Streamlined subcontractor distribution site workflow as part of lean project management
- Created and approved Enterprise Technical Rationales, such as the addition of NPI to the internal validated clean line
- Managed Suppliers adaptation of ZimVie GES 09802 cleaning requirements
- Involved in GMED EU MDR adaptation and Design Input-Output Traceability Matrix (DIOT) review
- Demonstrated expertise in Process Failure Mode Effects Analysis (PFMEA) and Qualification Documents (IQ, OQ, PQ) within the Supplier Production Part Approval (SPPA) Process
- Conducted SPC and SQC studies including Ppk and Gage R&R assessments to determine Acceptable Quality Level (AQL) reduction for suppliers
- SQE support for design transfer and NPI’s ensuring supplier sites are prepared and qualified for the new design and product launch
- Provided daily Supplier Quality support to ZimVie's downstream supply chain site
- Maintained and optimized the Approved Supplier List (ASL) by adding qualified suppliers and removing non-qualified ones
- Supervised SQE responsibilities for the EU MDR Contractor.
- Led cross-functional efforts to resolve complex supplier non-conformances, minimizing impacts on project timelines and budgets.
Quality Engineer
ZimVie -Previously known as Zimmer Biomet Spine
03.2019 - 01.2021
- SME and process owner for Non-Conformances
- Investigated and resolved over 1,000 NCRs, reducing backlog by 70%, while implementing new triggers and control charts to enhance trend analysis and corrective actions.
- Control, contain, investigate, and disposition non-conforming product ensuring the non-conforming condition has been corrected or escalated to a CAPA
- Developed and executed NCR trending via the use of control charts and SPC tools for all ZB Spine Sites
- Implementing corrective and preventative actions when deemed necessary
- Led Quality Circles to standardize inspection criteria, improving clarity and consistency
- Conducted GMP/GDP/Inspection technique training for operators/inspectors
- Investigated and managed Issue Evaluations (CAPA determination) stemming from trends or audit findings
- Triggered and approved Equipment Event Forms (EEFs) for inspection tools.
- Provided pivotal support for Issue Evaluations (CAPA determination) stemming from trends or audit findings
- Developed and revised Work Instructions, standard procedures, inspection criteria, and Quality Manual documents, delivering essential training on documentation updates as required
- Managed and conducted Quarterly Process Monitoring for cleaning of non-sterile implants and instruments
- Collected and analyzed water samples for the Reverse Osmosis water system of Getinge and Crestline systems
- Supported front room audits (MDSAP, Corporate, BSI) and led back room for the same.
Regulatory Affairs Specialist
Smith and Nephew
08.2021 - 12.2021
- Prepared US and EU Regulatory Submissions, contributed to regulatory strategies
- Created Certificate to Foreign Government for US markets and supported Audit room for product license information.
Quality Assurance Engineer II
Smith and Nephew
01.2021 - 08.2021
- Led the 444 Inspection review for new products, ensuring compliance and timely approvals
- Inspection Drawing creation and editing to fulfill new product requirement
- Conducted First Article Inspection and supported Product Development team during Functional Audits to ensure quality standards were met prior to production
- Oversaw the Quality Connections of new products in the Matrix (QMS), ensuring seamless integration and alignment with quality standards
- Initiated and managed Engineering Change Requests (ECRs), ensuring timely implementation
- Executed First Production Runs, conducting a comprehensive review of products prior to their transition into inventory
- Managed label review and approval on PRISYM ensuring compliance with Regulatory Standards
- Managed the ordering of gages and ensuring the availability of necessary tools for quality assessments.
Post Quality Engineer Intern
Medtronic Spinal & Biologics
12.2017 - 05.2018
- Created risk analysis and harms code templates organizing years of complaint data for complaint data analysis
- Developed a Preventive Action Trigger template for newly launched products, to proactively predict and address potential complications or complaints before they escalate to trigger thresholds
- Collaborated with senior engineers, actively participating in weekly team meetings by providing valuable input and contributing creative ideas to enhance project outcomes
- Assisted in updating files from the Medtronic database, to align with new EUMDR standards
- Create and revise documents as needed as well as creation of spreadsheets to track data.
Education
Bachelor of Science in Biomedical Engineering -
University of Memphis
Memphis, TN05.2018
Skills
- Supplier Development
- ISO 13485 and ISO 9001 Certified
- CAPA Investigation
- Lean Project Management
- Non-Conformance Management
- Audit Coordination
- Process Improvement
- Risk Analysis
- Team Leadership
- Internal Auditing
- Quality Management Systems
- Compliance Monitoring
- Corrective Actions
- Regulatory Compliance
- Continuous Improvement
- Quality Metrics
- Supplier Relationship Management
- Performance monitoring
- External Auditing
Certification
ISO 13485 and ISO 9001 Certified Lead Auditor
Leadership Experience
901UMMAH, Youth Program Director:
- Mentorship of youth through 901Ummah, a non-profit community organization dedicated to providing mentorship, cultivate talent, and empower young Muslims in Memphis through education, leadership development, and civic engagement.
- Organized and led youth engagement activities, including spiritual and leadership retreats, as well as local community events.
Timeline
Assoc. Quality Manager
Highridge Medical -Previously known as ZimVie
06.2024 - Current
Sr. Supplier Quality Engineer
ZimVie -Previously known as Zimmer Biomet Spine
01.2022 - 06.2024
Regulatory Affairs Specialist
Smith and Nephew
08.2021 - 12.2021
Quality Assurance Engineer II
Smith and Nephew
01.2021 - 08.2021
Quality Engineer
ZimVie -Previously known as Zimmer Biomet Spine
03.2019 - 01.2021
Post Quality Engineer Intern
Medtronic Spinal & Biologics
12.2017 - 05.2018
Bachelor of Science in Biomedical Engineering -
University of Memphis
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