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Process Auditor: Supplier Audits and Performance, Regulatory (ISO, OSHA,SAP, CFR, QSR) Expert

Technical Consultant #2464


Expertise

  • Process audit specialist; product audit and Quality Management Systems (QMS).
  • Lead 3rd party ISO Audit.
  • Advanced Product Quality Planning (APQP), Production Part Approval Process, PPAP and National Provider Identifier, (NPI) management.
  • Process improvement, value steam mapping and Lean Six Sigma.
  • CAPA, (Corrective And Preventative Action) engineering studies, Statistical Process Control (SPC) and 8D.
  • Team facilitating, regulatory compliance, ISO 9001, AS9100C, ISO 13485, QSR, 21 CFR (medical device), OSHA and SAP.
  • Tool validation, new and transfer.

Expert Witness Experience

  • Lead investigations for significant CoNQ (Cost of Non-Quality) recoveries when suppliers are at fault.

Experience

Undisclosed Company, Present, Sr. Global Supplier Quality Engineer, 2015 - Present

  • Lead all PPAPs (Product Part Approval Process) efforts for NPI and I2M.
  • Facilitate supplier audits and technical meetings to monitor and assess supplier performance, improve supplier communication, discuss existing or potential problems, review deficiencies, review analytical data, review improvement opportunities, identify new or improved technologies, and educate suppliers on company's and customer requirements.
  • Ensure adherence to the supplier qualification and approval process including the development of supplier qualification plans, collection and analysis of supporting data, and recommendations on long-term supplier viability.
  • Ensure adherence to the supplier management of change process including supplier monitoring, development of change qualification plans, collection and analysis of change data, and change impact recommendations.
  • Monitor the supplier nonconformance. Drive the implementation of robust root cause investigations, corrective and preventative actions.
  • Perform on-site supplier visits for root cause analysis and verification of corrective actions of supplier quality issues.
  • Review and evaluate supplier quality data to identify process improvement opportunities within the supply chain.
  • Drive supplier quality improvement programs.

Analogic, Peabody, MA, Sr. Supplier Quality Engineer, 2014 - 2015

  • Facilitate root cause analyses to develop permanent irreversible corrective actions.
  • Work with suppliers to generate permanent corrective actions utilizing 8d methodologies.
  • Champions supplier PPAP process and works with engineering to attain approvals.
  • Drive continuous improvement into the supply chain utilizing decisions based on data works with manufacturing and suppliers on measurement systems analysis studies to assure robust measurement systems are in place.
  • Work with suppliers to develops and maintain Process Failure Effects Analysis (PFMEA) and control plans for new and existing programs.
  • Determine statistical indicators to reduce or eliminate redundant inspections.
  • Perform external supplier audits, generates reports, and monitors performance.
  • Prepare quality reports on participates in design reviews during new product introduction.
  • Analyze production limitations and standards and recommends revision of specifications when appropriate.
  • Maintain the Qualified Supplier List ensuring all requirements have been achieved for qualified supplier status.
  • Update corporate supplier quality procedures in-line with ISO13485 and applicable standards whilst also ensuring best practices and incorporated.
  • Support project teams and program-level reviews and evaluations and facilitates efficiency and standardization.
  • Interfaced extensively to identify and resolve technical quality issues.
  • Supplier score cards to key suppliers. Developed strategic supplier audit schedule.

GSI Group INC, Bedford, MA, Quality Engineer, 2013 - 2014

  • Addressed customer related concerns on product issues.
  • Internal Auditor and lead 3rd party ISO Audit.
  • Oversaw CAPA program, Review returned material, develop metrics, and drive corrective action.
  • Lead supplier selection and qualification processes.
  • Drove corrective action processes within manufacturing, materials, engineering, and planning groups; design fixes, tests, processes.
  • Implemented lean practices within Operations to facility quality, cycle time, and inventory management improvements.
  • Participated in new product designs, redesigned existing products, qualification from First Piece Article, Prototype to mass production and support all after manufacturing events.

Invensys, Foxborough, MA, Sr. Quality Engineer, 2012 - 2013

  • Proactively coordinated and led functional interaction such as supplier quality assurance, transitions, material productivity, and cost reductions.
  • Utilized Six Sigma, Design for Manufacturing (DFM) tools to drive product and process improvement.
  • Ensured technical compliance with HS&E, OSHA regulations and requirements.
  • Led improvement of unit cost management including Cost Savings, Quality Measures, Product Cost, Productivity, Escapes, Inventory Reduction Projects and First Pass Yields.
  • Drove deployment of Built in Quality improvement findings, led the reduction in quality escapes, Cost of Poor Quality (COPQ), and Materials Review Board (MRB) utilization.
  • Facilitated all internal and regulatory audits as required.
  • Identify Root Cause Corrective Actions using processes such as Corrective Action Mistake-Proofing
  • Led improvements to achieve AOP in the following areas: On-Time Delivery, PPM, Escapes, Cycle-time Reduction, First Pass Yield, Turn Around Time, Inventory Reduction, COPQ and Safety.
  • Supported and led the implementation of continuous improvement actions (Kaizen); participate in Kaizen process.

Starmet Corp., (Advanced Specialty Metal), Quality Manager, 2005 - 2012

  • As Quality Manager, with focus to procure the company's ISO 13485 and AS 9100C recertified.
  • Team achieved their goal passing some of the biggest customer's audit such as Depuy, Medtronic, and Boeing.
  • Ensured compliance with national and international regulations and standards.
  • Met with the FDA Quality Systems Regulations, Current Good Manufacturing Practices 21 CFR 820.
  • Assessed the product specifications of the company and its suppliers, comparing with customer requirements.
  • Worked with purchasing staff to establish quality requirements from external suppliers.
  • Created a system to gather data for the weekly production meeting, and work on process improvement using the Six Sigma methodology.
  • Monitored performance by gathering relevant data and producing statistical reports.
  • Collated and analyzing performance data and charts against defined parameters.
  • Ensured tests and procedures are properly understood, carried out and evaluated and that product modifications are investigated if necessary.
  • Managed and maintained the Company's quality inspection and product release programs for incoming and in-process materials and components, processes and finished goods.
  • Formulated and managed the development and implementation of goals, objectives, policies, procedures and systems pertaining to the QA/QC.
  • Liaised with customers' auditors and ensuring the execution of corrective action and compliance with customers' specifications.

Tecomet Inc., Wilmington, MA, Quality Coordinator, 2002 - 2005

  • Managed quality aspects for this medical company, ISO 13485 certified, that designs, develops and manufactures orthopedic implants for surgical reconstruction and revision, trauma and maxillofacial applications.
  • Participated on cross-functional teams to facilitate new product introductions, process and procedural changes, and other tasks related to production support and Quality System management.
  • Assisted manufacturing and engineering personnel in preventive and corrective action (CAPA) investigation.
  • Part of the team that approved validations, FMEA, risk analyses, SOP and manufacturing and inspection procedures ensuring adherences to regulatory, global, internal and FDA requirements.
  • Performed analysis and identified trends in the inspection and finished products, in-process materials and bulk raw materials, and recommended corrective actions and process improvements.
  • Evaluated and analyzed the efforts in organizing, documenting, and interpreting inspection support documents and records.
  • Reviewed quality problems with both the supplier and engineering to determine actions required to correct defects.

Stroc Industries Inc., Casablanca, Morocco, Technician, 1994 - 2001

  • Quality technician, Quality Supply and Coordinator.

Honors & Publications


Credentials

  • Technology, Operations and Value Chain Management Executive Certificate. (MIT) Massachusetts Institute of Technology
  • Certified Quality Auditor. ASQ
  • Lean Six Sigma Black Belt Certificate. Quality Productivity Solutions

Languages

Speak write and read:

  • English
  • French
  • Arabic

License

  • Certified Quality Auditor, ASQ,

Education

  • M.S. Quality Systems Management, National Graduate School, Boston, MA
  • B.S. Mechanical Engineering. EduCatel, Rouen, France
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