Quality Engineer

ANBU ARASU

*** ***** ****, **

Acton, MA *****

978-***-**** (Res)

720-***-**** (Cell)

******@*****.***

SUMMARY

American Society for Quality certified Six Sigma Black belt and Operational

excellence Executive with

20 years of strong Leadership experience in Quality, Regulatory, Operations

and General Management in Multisites

Globally (In USA, Europe and Asia) with reputed Medical device, Aerospace

and Automotive companies.

. The Areas of expertise include:

FDA-QSR -GMP Regulatory Submission- FDA,

International

MDD, CMDCAS,CMDR, GHTF Labeling, Technical File Preparation

ISO 9001, ISO 13485,ISO 14971 QMS - Quality System Implementation

Implementation

510 K filings, IDE's, PMA's, IRB Regulatory Compliance -CE Marking

QSIT - Audits - Internal and Clinical Trials, Clinical QA Compliance

Supplier

Closed loop CAPA System Design Control, V&V, DHF,DMR,DHR

Six Sigma, Lean Manufacturing DFMEA, PFMEA, Risk Management, ECO

Process Improvement Leadership, Team Building

FDA Official Correspondent Management Representative

EHS, OSHA Compliance DEA,EPA Compliance

. 20 years of cross functional Management experience in Quality,

Regulatory, Operations,

Engineering, Product Management, Product development (Class III Class

II Products) Implantable

and disposable products, IVDs,Sterile and Non Sterile Products and

Regulatory

Compliance per FDA, GMP, ISO13485,14971, 14644-1, EHS- OSHA, EPA,

Supply chain, Human

Resources, audits and process improvements.

. Hosted and Managed FDA Inspections and ISO Notified body certification

Inspections.

. Manage FDA 510(k), IDE submittals and compliance to the Quality System

Regulations

. ASQ certified professional in Six Sigma Black Belt and in Operational

Excellence.

PROFESSIONAL EXPERIENCE

ESA BIOSCIENCES, Chelmsford, MA

2008 - 04/10

Director of Quality and Regulatory

Manage Regulatory and Quality departments responsible for regulatory

strategies, FDA and International Medical

device submissions and registrations. Assure compliance to the QSR, ISO.

Serve as FDA official correspondent and Management

Representative.

Accomplishments:

. Updated FDA Establishment registration and listings

. Hired and trained QA/RA personnel.

. Identified and developed action plans for compliance issues.

DRAGER MEDICALS, Telford, PA (A Drager and Siemens Company)

2007- 2008

Director of Quality and Process Management (Managed Multi sites

internationally- in USA (Telford PA)

and in Luebeck, Germany)

Accomplishments:

. Identified and benchmarked Quality KPI's and Key Targets for Products and

action Plans to address quality issues.

. Developed Quality and Organizational excellence strategic initiatives and

tactical projects to Protect Installed

Base, Gain Market Share, enhance operational excellence and sustain

profitability.

. Hired Personnel and trained them.

. Implemented closed loop CAPA system, Implemented and Harmonized Risk

Management per

ISO 14971 and corporate requirements that ensured product compliance and

safety.

. Reduced Open Complaints and average time for closure.

MEDTRONIC, Louisville, CO

2005- 2007

Sr.Quality Assurance Engineer

Accomplishments:

. Performed DOE, SPC, DFMEA, PFMEA, MSA, Gage R&R and Optimized Process

Capability at operations and at Suppliers facilities.

. Implemented MTBF and MTTR Targets for Key Products and Quality Plans to

achieve Targets.

. Contributed to achieve ISO 13485:2003 Quality System certification.

. Successfully Completed Six Sigma Projects in Operations, Finance and

Quality.

GUIDANT CORPORATION, Houston, Texas

2001 -2004

Sr. Process Quality Engineer

Accomplishments:

. Implemented 21CFR Part 11 Compliant CAPA system - Trained business to new

procedures.

. Implemented CMMS system (MP2) - Trained business to new procedures.

. Led cross functional Teams and successfully completed Operations, QA and

RA Projects.

. Optimized Production Processes using Six Sigma, Quality Tools.

BOEING COMMERCIAL AIRPLANE GROUP, Renton, WA

1998 - 2001

Lead Manufacturing Quality Engineer (Multisites - Everett, Renton, WA)

Accomplishments:

. Implemented Lean Manufacturing in 7x7 Next Generation Production and at

Suppliers which

reduced rejects and increased productivity, quality and efficiency.

. Led cross functional Quality Improvement and Lean Manufacturing Teams and

successfully completed Projects

in Multiple facilities at Everett and Renton Plants.

UNITECH ENGINEERING, Chennai, India

1989-1998

Plant Manager

Accomplishments:

. Prepared AOP and executed projects successfully to achieve corporate

G&O's.

. Successfully led Cross functional Operational Improvement Projects and

TQM Initiatives.

. Hired and trained Personnel in Operations, Manufacturing Engineering and

Quality.

. Implemented ISO 9000 Quality system - Trained stakeholders.

. Led the Team of lead auditors, assessors and obtained ISO 9001

certification.

EDUCATION

MS (Regulatory Affairs - Currently in Progress ) Northeastern

University, Boston, MA

Bachelor of Science, Mechanical Engineering, Annamalai University,

Chidambaram, INDIA

COMPUTER SKILLS

Experienced in Minitab, Trackwise, Catsweb, Agile PLM, Metaphase PDM,

MP2 CMMS,, AS400, MRP system, ERP systems ( SAP, Oracle, Baan-V ) MS

Access, PowerPoint, Project, VISIO.

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