DANA RICHARDSON

** ****** ******

Medford, MA ***55

781-***-****

339-***-****

Quality Professional with over 20 years of experience within the Aerospace, Defense and Medical industries. Strong Supplier Quality Engineering, Auditing and inspection experience.

Areas of Expertise:

AS9100, ISO9001, ISO13485, ISO14971

IEC62301, IEC60601, 21CFR Part 820

FMEA, PPAP, SPC, Root Cause Analysis

Geometric Dimensioning and Tolerance (GD&T)

Certification/Training:

AS9100 Lead Auditor Certification

ISO9001 Internal Auditor/ Lead Auditor Certification

Root Cause Analysis Training

FMEA Certified

Certified Precision Mechanical Inspector ASQ

Experience:

Takeda 2020 – Present

Supplier Quality Specialist

Perform the execution of the Global Supplier Quality and Material Management programs at the MA Bio Ops Plant

Perform the execution of qualification, maintenance, and monitoring for the plant’s suppliers, with an emphasis on continuous improvement, global alignment, risk management, and supply chain reliability

Support local cross functional stakeholders and stakeholders in the Biologics OPU

Unitek Technical Services, Inc. 2019 – 2020

Technical Specialist

Perform critical Precision Mechanical Inspections and QMS Audit Services

Perform weekly Government Source Inspections at Colt Manufacturing’s supplier Rosco Manufacturing

SQA Services Inc. 2018 – 2019

Senior Supplier Quality Engineering Consultant

Conducted initial Zero Defects Program assessments to major manufacturing suppliers (on behalf Harris Corporation)

Assisted with the implementation of APQP

Trained supplier employees to AS9102 First article submittal

Gage R&R studies and provided source inspection activities

BAE Systems, Inc.: Nashua, NH 2016 – 2017

Performance Excellence Engineer (QAVMI) (Contract)

Verification, validation, and visual mechanical inspection for the end item acceptance of hardware

Confirm compliance to ever-evolving quality procedures, work instructions and software packages

Review, understand, and interpret documentation, drawings, specification and data

Test Devices, Inc.: Hudson, MA 2016 -2016

(Design/Manufacture Test Equipment for Rotating Turbine Components)

QUALITY MANAGER /Quality Engineer (Contract)

Created and managed processes that ensured corporate product/service quality standards were met

Ensured all specification met with manufacturing and legal requirements

Worked with manufacturing, engineering, suppliers, and customers on quality related issues

Managed and performed audits per ISO 9001 & AS 9100

Provided oversight for the calibration of all measuring and test equipment

Reviewed customer and supplier contracts for potential quality issues

Investigated root cause analysis of non-conformances and developed corrective actions

Responsible for continuous improvements and preventative actions

Gentex Corporation: Boston, MA 2014 - 2015

(Manufacture Advance Head Protection Helmet Systems)

QUALITY MANAGER /Quality Engineer

Lead continuous improvements efforts in support of the QMS (ISO 9001 or AS 9100)

Optimized the development, analysis, and utilization of QMS data to support continuous improvements efforts and measurements of QMS effectiveness for management review

Coordinated and Lead Internal QMS audits

Lead and participated in continuous improvement teams

Reported Quality metrics to Senior Leadership Team

Reviewed customer contracts include military specifications to ensure compliance

Mentored and trained inspection personnel and junior engineers

Lead root cause analysis & corrective action teams

Interfaced with customers and Design engineering to define & document acceptance criteria into quality plans, and insure their proper execution

Partnered with supply chain to evaluate & measure supplier performance

Represented Quality in the New Product Development Process as required

JLG Industries: Hagerstown, MD 2013 - 2014

(Manufacture of Aerial Work Platforms)

PRINCIPAL SUPPLIER QUALITY ENGINEER

●Performed Quality System audits at Supplier locations globally

●Collected Quality Metrics and reported monthly to Executive Management

●Developed Methods and robust processes to reduce PPM

●Maintained nonconforming records and reviewed with suppliers weekly to determine root causes

UTC Power; South Windsor, CT 2012-2013

(Manufacture of Hydrogen Fuel Cells)

SUPPLIER QUALITY ENGINEER

●Provided expertise and insight to address high-visibility Quality issues within global organization

●Reduced inspection cycle times using lean manufacturing principles

●Drove corrective and preventive actions through collaborative efforts with Material Review Board (MRB)

●Prepared first article data packages per AS9000 in addition to customer specifications

●Ensured conformance to PPAP requirements through performance of rigorous supplier audits

●Addressed supplier issues through initiation of root cause analysis

Tark Inc.: Billerica, MA 2009- 2012

(Manufacture of Cooling Pumps for Hospital Ultrasound Machines & Security Systems)

QUALITY ENGINEER

●Supervised receiving and in process Inspectors

●Performed Internal and external Corrective and Preventive Actions (CAPA) Investigations to insure regulatory compliance with standards such as ISO 13485, ISO14971, IEC60601, IEC62301 and CFR Part 820 for medical devices & Contributed through active participation in MRB meetings.

●Designated to act as Failure Mode Effects Analysis (FMEA) Team Leader.

●Performed daily disposition of material from all areas of manufacturing floor, including rejected material from incoming inspection as well as assembly floor

●Created and implemented comprehensive rework order system

●Maintained current spreadsheets of MRB activity

Spincraft; Billerica, MA 2007 - 2009

(Manufacture of Rocket Domes for Aerospace)

SUPPLIER QUALITY ENGINEER

●Interacted with all major Aerospace and Power generation customers for all Quality related matters

●Prepared first article data packages per AS9000 in addition to customer specifications

●Reviewed incoming customer contracts and incorporated quality requirements into manufacturing plans and sub-tier supplier purchase orders

●Performed manufacturing process and statistical capability studies

●Participated in qualification testing of new processes and materials

●Created supplier-rating system and tracked quality metrics to correct customer issues

●Interfaced daily and worked collaboratively with Manufacturing, Engineering and Inspection personnel

●Maintained superior relations and communication with customers, suppliers and special process vendors

Pratt & Whitney Aircraft Corporation: East Hartford, CT 2005 - 2007

(Manufacture of Turbine Fan blades for Aircraft Industry)

QUALITY ENGINEER/QUALITY AUDITOR

●Maintained quality system using internal audits and providing engineering support in Turbine Module Center

●Analyzed root cause of failures—including supplier-caused nonconformance—and instituted solutions for eliminating possible failure causes

●Attained AS9100 B Auditor certification

●Ensured overall shop compliance to customer requirements

●Ensured critical testing requirements were met through provision of expert engineering technical support to assembly area

●Compiled customer certification packages including material certifications and test reports

●Coordinated product assembly with customer delivery requirements and presented certification data packages to customer including first article data

●Provided exceptional engineering support to group of 11 Quality subordinates

●Coordinated all quality requirements between manufacturing engineers and shop personnel

●Conducted exacting review of Production Part Approval Process (PPAP) criteria

●Determined FMEA candidates through review of machine shop processes using Statistical Process Control (SPC)

●Ensured customer satisfaction through provision of hands-on technical support

Middleton Aerospace Corporation: Middleton, MA 2001 - 2004

(Manufacture of Large Machined Jet Engine Components for Aerospace industry)

SUPPLIER QUALITY ENGINEER

●Generated quality plans for operation of new complex turbine casing contracts per customer requirements

●Analyzed root cause of failures—including supplier-caused nonconformance—and instituted solutions for eliminating possible failure causes

●Reduced inspection cycle times using lean manufacturing principles

●Modified quality plans using statistical process methods

●Acted as Team Leader for FMEA

●Prepared first article data packages per AS9000 in addition to customer specifications and presented completed packages to customers including DCASMO, FAA, General Electric Aircraft Engines, Volvo Aerospace and Rolls Royce

●Authorized RMA’s (Return Material Authorizations) as necessary to return defective product

●Prevented costly recurrences through scrupulous investigation of defects

Palmer Manufacturing Company Inc.: Malden, MA 1991 - 2001

(Manufacture of Precision Machined Jet Engine Components for Aerospace industry)

PROCESS ENGINEER

●Investigated and documented all causes and corrective actions generated on manufacturing floor

●Improved manufacturing processes continuously through utilization of lean manufacturing techniques

●Overhauled gauge-making room and calibration laboratory as Kaizen leader

●Developed and implemented Workplace Apprentice Training Program in manufacturing technology.

QUALITY AUDITOR

●Managed team of eight Internal Quality Auditors as well as evolved into certified ISO 9000 Auditor and designated primary ISO 9000 representative

●Wrote quality manual, procedures and checklists in accordance with ISO 9002

●Conducted training which resulted in ISO 9002 registration and AS9000 certification

●Designed and implemented methods for efficiently managing extensive supplier base companies

●Successfully reduced supplier nonconformances from $360K in first three quarters of 1998 to $50K in same period of 1999 as well as reduced supplier cost to $28K in 2000

●Acted as corporate spokesman for customer quality audits, including FAA, United States Navy, Pratt & Whitney, General Electric Aircraft, and Volvo Aerospace

Education:

Northeastern University – College of Engineering B.S. Mechanical Engineering

Massachusetts Institute of Technology- Design and Manufacturing

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