Supplier Quality Manager
Resume:
Aaron Lupo
Auburn, NY *****
*******@*****.***
SUMMARY:
Eighteen years plus years of increasingly responsible quality, sourcing, engineering, and production experience supporting the manufacture of high volume and mixed model medical devices and custom components for the medical device industry. Bachelor’s degree in Quality and Manufacturing Engineering.
PROFESSIONAL EXPERIENCE:
Raytheon Auburn, NY December 2017 - Present
Supplier Quality Manager (December 2017 to Current)
Develop Supplier/Subcontractor Quality Surveillance and Engagement Plans for Business-Critical Suppliers
Provide on-site supplier/subcontractor engagement including monitoring / assessing processes and engaging in proactive improvement initiatives
Collaboration with other Raytheon Quality functions and Cross Business Teams to affect rapid closure of issues.
Perform Supplier Assessments, Purchase Order Flow down Reviews, First Article Inspection acceptance, assuring compliance to Quality Notes and Special Process requirements, in-process inspections and final Raytheon product acceptance.
Conduct supplier/subcontractor performance reviews and identifying improvement opportunities
Responsible for managing supplier-caused nonconforming product from investigation through corrective action implementation.
Monitor supplier’s ongoing performance based on their non-conformances, first pass yield, scrap, CpK/PpK, on-time delivery, documentation review such as DHRs, batch/lot records and in-house Cost of Poor Quality, Supplier Corrective Action Requests (SCARs).
Welch Allyn, Inc., A HillRom Company Skaneateles Falls, NY 2004– November 2017
Supplier Quality Manager (2014 to Current)
Implemented and managed a risk-based global supplier management system which improved all aspects of supplier management and purchasing controls including supplier selection, communication, monitoring, and development.
Developed and trained on global SOPs, Work Instructions, and Forms/records compliant to 21CFR820, ISO 13485, CMDR, and MDD documenting assessment activity.
In partnership with Global Sourcing, developed and implemented Commodity Teams to manage key suppliers in multiple strategic commodities including Lean techniques.
Manage a global team conducting supplier quality system and process assessments.
Direct interaction with FDA and ISO auditors.
Manage a direct staff of four senior supplier quality engineers responsible for an active supply base of over 1700 materials in commodities ranging from metal fabrication and plastic injection molding to printed circuit board assemblies and finished device manufacturing. This represented a spend of $330 million across 90+ medical device product families including hand held diagnostics, point of care vital signs monitoring, women’s health, cardiopulmonary, endoscopy, exam lighting, and thermometry.
Responsible for managing supplier-caused nonconforming product from investigation through corrective action implementation and IQ/OQ/PQ activities in supplier’s processes.
Monitor supplier’s ongoing performance based on their non-conformances, first pass yield, scrap, CpK/PpK, on-time delivery, documentation review such as DHRs, batch/lot records and in-house Cost of Poor Quality, Supplier Corrective Action Requests (SCARs).
Engineering tools include: DMAIC - Six Sigma, PFMEA, Design of Experiments (DOE), IQ/OQ/PQ validation, Process Control Plans, 5-Why, Ishikawa, Gage Repeatability and Reproducibility (GR&R).
Supplier Quality Engineer (2007 to 2014)
Performed internal and supplier compliance audits. Assure corporate compliance by auditing internal quality systems, outsourced activities such as software and hardware vendors, contract research organizations (CRO's), major subcontractors and independent annual audits of Welch Allyn facilities.
Standards used include FDA QSR, GCP standards, ISO 9000, ISO 13485, EU MDD and other appropriate standards as related to Welch Allyn Quality Systems
Responsible for training and developing members of the Global Audit Team, located at various Welch Allyn sites.
Responsible for supplier management activities including process mapping, FMEA’s, variation reduction studies/CpK improvement projects, as well as throughput reduction and application of lean supply chain techniques.
As a Supplier Quality Engineer I am instrumental in performing supplier audits, evaluating supplier metrics and performing engineering-based improvements at suppliers.
Utilizing my strong facilitation skills, to lead meetings with key partners to ensure timely implementation of these activities.
Verified that supplier files are maintained and documented appropriately.
Follow-up with suppliers and Sourcing to assure timely implementation of SCARs and provide supplier metrics to management as required.
Leading a project to reduce the number of defects received from suppliers, first year saw a 50 percent reduction in the number of nonconforming material reports generated.
Quality Systems Auditor (2004 to 2007)
Responsibilities include: ensuring compliance to ISO, FDA, and EN Standards. Conducts process and product audits required by FDA/ISO audits for the various departments. Ensuring compliance to various regulatory groups FDA, EU, NSAI, ISO. Assisting production associates in proper completion of DHR’s as needed, signing completed DHR’s after verification to Manufacturing Specifications and DMR’s.
Reporting metrics to Management.
Working with Process Engineers to improve processes as needed. Responsible for initiating and following-up on NMR’s on suspect product both internal and external.
Responsible for initiating and following-up on Corrective Actions as a result of line audits. Responsible for assisting on New Employees Orientations as needed. Reviewing Corrective and Preventive actions for effectiveness.
Sterilization Technical Services Rush, NY November 1999 - May 2004
Corporate Quality Systems Specialist
Responsibilities included include: ensuring compliance to ISO, FDA, and EN Standards.
Responsible for coordinating the internal audit program, supplier, client audits, and for ISO/FDA GMP/EN compliance audits; coordinating and managing the Corrective Action/Complaint Program; ISO/EN Certification activities of the STS Companies.
Responsibilities include extensive customer interaction which include Managing the Supplier Quality Review Board/Supplier Quality Program, escorting and answering Client technical/quality questions and concerns, ensuring compliance to various regulatory groups FDA, EU, TUV, KEMA and for writing, reviewing, participate in the creation of Technical dossiers, and revising operating procedures.
Interpreting Regulatory Requirements for the Manufacturing Department, Process Engineering, Managing the Document Control System, including the ECN/ECR process.
Conducts process and product audits required by FDA GLP audits for the various departments.
As the Management Representative, responsible for ensuring that the quality system is established, implemented, and maintained in accordance with the ISO/EN Standards, reporting on the performance of the quality system to the STS management review and as a basis for improvement of the quality system, acting as a liaison with external parties relating to the STS quality system.
Successfully completed a transition course in ISO 9001:2000. Prepared and delivered a presentation for the American Society for Quality on ISO 13485:2003
EDUCATION:
Rochester Institute of Technology, Rochester, New York
Bachelors Quality Engineering/Manufacturing
Cayuga Community College, Auburn, New York
AAS Business Administration
Rochester Institute of Technology, Rochester, New York
BSI ISO-9000 Lead Auditor Course
PROFESSIONAL TRAINING, INTERESTS, AND HOBBIES:
JIT/Lean Principles
Lean Six Sigma
Process Validation
DOE
SPC
SAP
Negotiating Skills
Design Control
Software validation
ISO 13485 Lead Auditor
Leadership Cayuga
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