Alix Saint-Franc

703-***-****~ adbxhm@r.postjobfree.com (Page 1 of 3)

PROFESSIONAL PROFILE

A knowledgeable ASQ Certified Manager of Quality who possesses over 20 years of experience in providing quality support for the manufacturing of electronic products and systems including PCBs, CCAs, ECAs, Cable & Harnesses and management of Quality Engineering, Supplier Quality and who can develop, plan and direct the development and implementation of systematic approaches to obtaining efficient and effective results with emphasis on:

-Experience in the deployment of corporate strategic quality objectives to tactical and operational levels.

-Prominent Representative of the “Voice of the Customer” and Employees Health & Safety

-Implementation of Total Quality, APQP, PPAP, Lean principles and practices for manufacturing environment.

-Possesses hands on experience in using advanced quality tools used in process improvement programs.

-Has the ability to independently to plan, design, deploy, implement, execute and oversee Quality and Regulatory Management in compliance with, AS9100, ISO9001, ISO 13485, ISO17025, TS16949. CMMI and SDLC Methodology, MIL-STD’s, FCC, UL, ASME, NADCAP and ANSI to support Lean Manufacturing or Six Sigma Environment.

-Possesses experience in Total Quality Management and Quality Strategic Planning to be incorporated and align with Corporate Strategic Plan, Vision and Quality Statement and Commitments.

-Familiarity with a variety of MIL-STDs, ERP Systems and SPC Software Packages including Minitab Software.

BACKGROUND AND STRENGTHS

AREAS OF EXPERTISE: Management of Quality Management System, Management of Quality Engineering, Supplier Quality with strong ability in Reliability Engineering, Environmental, Safety, Regulatory, Process Engineering, Component Engineering, Product Development Engineering, Project Management, Risk Management and NPI.

-COMPETENCIES: Customer focus, Creativity and Innovation, self-starter, Initiative, persuasiveness, analyst, flexibility/adaptability, teamwork and ability to undertake quality planning and deployment with accuracy.

-MANAGEMENT SKILLS: Strong Management Skills including Knowledge and Project Management.

-QUALITY STANDARDS: AS9100, ISO9001, ISO 14001, TS16949, ISO17025, ISO13485, ASME and NADCAP

-REGULATIONS/ACCREDITATIONS: NACAP, ANSI, UL, CEC, NTS, ETSI and NEBS

-TOOLS: Quality Management tools, SPC, DMAIC, FMEA, PPAP, DOE, 8-D, CAPA, 5S, 6S, Gage R&R and DFR.

-INDUSTRY: Manufacturer of Computing Equipment, Transportation, Aerospace, Military & Defense Equipment.

EMPLOYMENT HISTORY

DIRECTOR OF QUALITY (FIRST SOURCE ELECTRONICS): April 2019 – November 2019

●Management and continuous improvement of Quality Assurance and Quality Control processes to drive excellence in Manufacturing of Cables, Electronic, Control Panels and Mechanical assemblies for Military, Aerospace, Power Management, Rails Locomotive and Transportation Industries.

●Complete Management of Supplier Quality (Qualification, Approval and Disapproval)

●Supervise Lab& Equipment, Internal and External Audits and work to ensure compliance to ISO 9001

●Performed APQP, PPAP Process evaluation and generate Report to be submitted to Senior Management

DIRECTOR OF QUALITY: THERAGEN Inc: November 2016 – April 2019

●Oversee the entire Quality Organization including Management and continuous improvement of Quality Assurance and Control Processes to drive excellence in Manufacturing, of PCBs, ECAs and Mechanical Parts

●Complete Management of Supplier Quality (Qualification, Approval and Disapproval)

●Responsible for Internal and External Audits to ensure compliance to ISO 9001 and ISO 13485

●Prepare DHF, DMR, DHR, Technical files and Risk Management documentation for all Medical Devices

●Provide Guidance in driving the Quality Tactical and Operational deployment to meeting the Corporate Strategic Objectives and agenda.

Alix Saint-Franc 703-***-****~ adbxhm@r.postjobfree.com (Page 2 of 3)

●Management of corporate continual improvement initiatives, supplier processes, and ensures fast resolution of complaints and process deficiency to reduce the Cost of Poor Quality (COPQ).

●Results: - Obtain Certification of ISO9001, ISO13485, CMDCAS, DMEPOS and CE Mark (by BSI)

CORPORATE DIRECTOR OF QUALITY: MTEQ: January 2014 – November 2016 (Promoted from Sr. QA Manager)

●Oversee the entire Quality and Safety Organization including QMS, Supplier Quality Management, Quality Engineering Management, Regulatory and Safety for all five MTEQ sites including several direct reports.

●Determines operational strategies and exercises judgment to define procedures and policies to accomplish corporate and departmental objectives and lead the execution of those strategies for client’s contracts

●Manage the Quality Control and the Improvement & efforts to meet standard turnaround times and labor efficiency to reduce the Cost of Poor Quality (COPQ) in manufacturing of PCBs, ECAs, Cables & Harnesses.

●Ensure all manufacturing locations maintain Certification of ISO9001, ISO13485, AS9100, ASME and NADCAP

●Ensure the manufactured products comply with all applicable Aerospace and Military Standards as per contracts

●Management of corporate continual improvement and provide guidance in driving the Quality Tactical and Operational deployment to meeting the Corporate Strategic Objectives and agenda.

●Supervise Test Lab & Equipment, Audits and work to ensure compliance to ISO 9001 and ISO17025.

●Provide IPC-610 Training to all Quality Inspectors and Electronic and Electromechanical Assemblers.

●Results: - Reduce waste and defect rate by 70% which save the product line about of millions over the past two years. Reduce cycle time that leads to accost saving of tens of thousands per month over two years. - Passed both ISO9001 and AS9100 and Health & Safety audits with zero non-conformance.

Sr. QUALITY ENGINEER IV: DRS DEFENSE SOLUTIONS: February 2012 – Jan 2014

●Consistently initiated quality improvement initiatives and processes across a line of business unit in support of Production of PCBs, CCAs, Cables and Harnesses under ISO 9001 and AS9100 Quality Management Systems.

●Collaborates with program managers, design engineers and manufacturing engineering by participating in risk analysis, design FMEAs and process FMEAs supporting Aerospace, law enforcement and military contracts.

●Manage the Supplier Quality program including the Approve Vendor List (AVL) for the entire company. Collect quality data and metrics on suppliers to evaluate their performance and issue Score Cards. Supplier Qualification, Supplier Approval/Disapproval

●Plan, manage, and direct quality assurance activities supporting devices, Aerospace and Military Contracts

●Coordinate yield/data reporting and conduct trend analysis of process using Minitab Software Package

●Team up with other Departments to improve quality, reduce costs and maintain on-time deliveries.

●Closely partner with the Design& Development organization to drive robust design transfer and long-term new product introduction success that are manufactured per all MIL-STD’s as per contract agreements.

●Design, oversee, manage and participates in quality system projects, and improvement projects

●Act as a very effective change agent who facilitates change innovative approaches to addressing problems.

Results: -Reduce waste and defect rate by 80% which save the product line about 3.5 million over 14 months.

- Assist in increasing the maturity level of CMMI from Level 2 to maturity Level 3.

LEAD QUALITY ENGINEER: ARIES GROUP/GENTEX CORPORATION: May 2010 –February 2012

●Responsible for designing quality improvement initiatives and processes across a line of business unit.

● Support the Production of PCBs, CCAs, Cables & Harnesses and Complete Systems for aerospace and Defense under ISO 9001 and AS9100 Quality Management Systems.

●Manage the Supplier Quality program including the Approve Vendor List (AVL) for the entire company. Collect quality data and metrics on suppliers to evaluate their performance and issue Score Cards. Supplier Qualification, Supplier Approval/Disapproval

●Planed schedule and managed internal and external audits including: FAA, DCMA, NAVAIR and Third Parties.

●Coordinate yield/data reporting and conduct trend analysis of process using SPC and Minitab Software Package

●Team up with suppliers to improve quality, reduce costs and maintain on-time deliveries of supply chain

●Closely partner with the Design & Development organization to drive robust design transfer and long-term new product introduction success.

●Design, oversee, manage and participates in quality system projects, and improvement projects

●Drive the Quality issues agenda, including CAPA, global customer warranty, complaints and MRB.

Alix Saint-Franc 703-***-****~adbxhm@r.postjobfree.com (Page 3 of 3)

●Manage and develop all quality personnel including Lower level quality engineers and inspectors and other quality associates.

●Lead preparation for Government and other 3rd party audit, serve as the POC during the audit and drive resolution of open items after the audit.

●Perform APQP, PPAP, statistical analysis on all collected metric data using Minitab Software.

Results: -Reduce waste and defect rate by 60% which save the product line about 2.5 million over 16 months.

- Reduce production cycle time that leads to accost saving of $1.6 million over the past 26 months

-The Company obtained a large contract with the US because of the Quality Structure put in place

QUALITY MANAGER: TWIDC TEST & VERIFICATION: February 2003 - May 2010 (Assigned to Devol)

●Assigned to several OEM and technical service providers to overseeing their entire Quality Organization and ensure internal policies, customer expectations, and regulatory requirements are met.

●Provided technical consulting at the customer manufacturing facilities to engineers and project teams on product approval issues related to APQP, PPAP, UL, EMC, NEBS, ANSI, CEC and product safety.

●Assess quality-related issues associated with business development activities and provide guidance.

●Consistently Identify opportunities to reduce waste and increase efficiency across the company and its clients.

●Ensure QA team and employees use quality tools to improve the company’s accuracy, efficiency and profitability

●Provide technical direction and guidance to others regarding processes, tools and technology related to quality

●Ensure Facility remains in compliance with MIL-STD’s, AS9100, ISO9001, ISO 14001, ISO 13485 and ISO 17025

●Perform supplier facility audits, supplier quality and internal audits, and develop audit reports

●Resolve material and process issues affecting product quality and initiate CAPA actions as appropriate.

●Work with suppliers and Purchasing to achieve timely and comprehensive corrections and future prevention.

Results: Between 2004 and 2006, the company has signed five (5) contracts for more than seven million dollars due to the robust Quality System and structure we put in place.

QUALITY and RELIABILITY LAB MANAGER: TELLABS OPERATIONS INC: June 1997-December 2002

●Managed and supervised the reliability and process test laboratories under AS9100, ISO 9001 and ISO 17025.

●Responsible for designing quality improvement initiatives and processes across a line of business unit.

●Provided technical consulting at the customer manufacturing facilities to engineers and project teams on product approval issues related to MIL-STD’s, FCC, UL, EMC, NTS, ETSI, NEBS, ANSI, CEC and product safety.

●Develops and recommends corrective actions to Safety and EMC non-compliance and product-related hazards

●Lead the Quality Team on finding resolution of product reliability and safety issues by analyzing, developing, revising and resolving product safety processes through FRACAS Quality Complaint Report System.

●Performed reliability studies of new process, material and components to generate adequate report.

Results: Planned, designed, and built a state-of-the-art Reliability laboratory which enable Tellabs to conduct its own reliability testing that lead to a total saving of more than $600,000 over 3 years.

EDUCATION /TRAINING

Johnson & Wales University Providence, Rhode Island

-December 1992: Bachelor of Science Electrical/Electronic Engineering with a GPA of 3.67.

-Certified Manager of Quality /Operational Excellence (CMQ/OE)

-Certified Trainer for IPC-610

-Certified Internal Quality Auditor

-Successfully completed the full training for Six Sigma Black Belt.

-Practical knowledge of Lean Manufacturing

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