Medical Device Quality

Mahmud Ahmed *** New Britain Avenue Farmington, CT 06032

Cell; 860-***-****

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

Citizen of the United States

EDUCATION & PROFESSIONAL ACCREDITATION:

Master of Science- Quality Assurance Management- State University of California @ Dominguez

Hills- California- 2000

Bachelor (Physics)- University of Hartford, W. Hartford CT -1981

ISO 9000 Lead Auditor Certified- 1996

Medical Device Lead Auditor course ISO 13485:2003 -2005

CE-Mark 93/42/EEC Certified- 2005/2009

Lead Auditor RAB/QSR # 08807- Certified 1996

Certified Quality Auditor: American Society for Quality # 16217-Certified 1996

Certified Risk Assessment Lead Auditor Course- Certified 2007

Certified Canadian Medical Device Certified Auditor course by Health Canada- Certified 2006

Certified PAL Auditor Course by Japanese Ministry of Health, Japan- Certified 2007

Certified Taiwan Medical Device Regulations Certified-2007

Australia TGA- Certified 2007

Quality System Regulations 21 CFR 820, 806, 810, 821, 822, Part II, IDE, PMA, 510(K) IRB

TL 9000 Requirement 5.0/5.0

TL 9000 Lead Auditor Certified- 1999

ISO 14001: Environment Management System

Six-Sigma methodology-2005

Validation & Verification Expert

Employment History:

Senior Quality and Regulatory Engineer/Senior Supplier Quality Engineer

Philips, Hospital Respiratory Care

Philips Healthcare

July 2011- April 2013 (Full time)

Ensure Suppliers deliver quality components, material and services. This involves defining, creating and implementing

processes of key systems as it relates to supplier selection, classification, supplier auditing rating and development

systems. Total responsibility for supplier monitoring, conformance and sustainability to ensure the unit/Sector

requirements are met fully. Evaluation of the supplier’s internal functions to assess their overall performance,

providing feedback with respect to their operations and resolution of supplier related problems as it affects the

unit/Sector fall under the purview of their duties. Support compliance to the FDA QSR 820, ISO 13485:2003 &

9001:2008, and ISO 14001, CE-mark 93/42/EEC, Canadian medical device Regulation part I, Japan PAL regulation

and other mandatory domestic and international certification requirements. Attend professional development training

courses to keep with most up to date cutting edge technologies. Responsible for Internal Audit Planning, Execution and

follow up of corrective and preventive actions. Provide opportunity of improvement to suppliers//vendors for process

optimization. Internal Quality Audits planning, Execution and management according to approved PHILIPS Annual

Internal Audit Plan, Provide Expert knowledge input to management regarding addressing issues to Third party

Regulator and Notified bodies. Provide Expert knowledge to Engineering Projects for advance Quality planning, New

Product development and enhancement of current projects. Provide Quarterly progress report to management review.

Conduct Auditor Training classes for Philips Internal auditors, qualify and certify staff.

Support the New Product Introduction, Cost Reduction, and part resourcing activities

thru the completion of supplier validation of Company designed parts/assemblies. Collect review and summaries

validation objective evidence and issue supplier CAPA as appropriate. Complete data reviews to assure that process Cp

and Cpk are at acceptable levels. Manage supplier thru the review of supplier performance data, communication of

supplier performance with supplier, driving improvements in supplier’s deliverable quality, review and validation

of supplier proposed changes and completion of supplier improvement audit as needed., Support R&D, component and

purchasing organization with the identification, assessment and qualification of new suppliers/Vendors (Domestic and

International)

DNV Certification, USA

Lead Auditor/Client Manager

Quality Management System & Product certification

2009- July2011 (Full time and Contract)

Conducting client’s certification and Product certification audits under schemes specific rules such as ISO 9000:2008,

Medical Device ISO 13485:2003, MDD 93/42/EEC,, TL 9000 5.0/4.0

Planning & executing the audit process, using available resources. Attend professional development training courses as

directed by client office in order to keep with most up to date cutting edge technologies. Review and examine Client’s

Quality Management System documents, policies and procedures to certify them per scheme specific rules and

requirements. Conduct Risk assessments and Clinical trial data analysis. and prepare audit report, Periodic audit plans,

document non conformities, observations and Noteworthy efforts identified during audit process, recertification plan

and expense report. Communicate clients, Client office and other Audit team members in Planning, Pre audit

preparation and post audit closure of Non conformities identified in the Audit process, if necessary conduct special

audits, preliminary audits etc.

BSI Management System, USA

Lead Auditor/Client Manager- 2005- 2009 (full time)

Medical Device, Quality Management System Assessment Lead Auditor Conducting primarily ISO 9000, TL 9000,

ISO 13485:2003, CE Marking 93/42/EEC, Canadian Medical Device Regulation Part 1, Japan Pharmaceutical Affairs

Law, Taiwan Medical Device Regulations and other International requirements.

Conduct Risk assessments and Clinical trial data analysis data and reports, Batch verification/release using appropriate

qualified sterilization standards, asses Facility infrastructure for qualifying Sterilization Suppliers, Sterile product

release and Competency of people managing sterilization process. Planning & executing the audit process, using

scheme specific requirements. Managing and creating as necessary documentation reports, agenda and recertification

plan. Making travel arrangements and prepare expense reports. Attend professional development training courses as

directed by the scheme requirements and CB in order to keep with most up to date and cutting edge technologies.

Review Client’s Quality Management System documents, policies and procedures to qualify them per scheme specific

rules and requirements.

CAS Medical System, Branford CT

Designer & Manufacturer of Medical Devices

ISO13485:2003 registered Company

Senior Quality Engineer: 2002–2005 (Full time)

Responsible for maintaining the total Quality Management system integrity and interface with internal and external

customers, including Third party Regulatory Assessment organizations, FDA, and other medical device design and

development organizations. Risk assessment analysis and Clinical trial planning

Manage Corrective and Preventive action/complaints/ post market surveillance, vigilance and Medical device

complaint analysis reporting and corrective action implementation activities, Serve as a Quality Assurance

Representative in Medical device design and development projects, Internal Quality Audit planning, scheduling and

executions, Inspection and test and medical device qualifications and approval with cross functional environment,

responsible for customer complaints tracking, trending and follow up on investigations including field actions Evaluate

design, processes and material changes to existing products to ensure compliance with all regulatory bodies, Conduct

performance evaluations. Responsible for management of Medical Device Regulatory and Quality Management

system, interface with FDA, third Party Regulatory bodies, Supplier and customers. Maintain and organize Design

Master/History Records (DMR, DHR) Prepare and submit to US FDA pre market submissions (510K), licensing and

communication up to date on daily basis. Review global regulations, guidelines and acts as compliance resource, Train

and qualify work employees in their job duties. Manage medical device design and development project with clients

and customers as a team member in a cross functional environment.

Responsible for management of Medical Device Regulatory and Quality Management system, interface with FDA,

third Party Regulatory bodies, Supplier and customers. Recruits, coaches, and developed organizational talent, fosters

a diverse workplace that enables all to contribute to their full potential, Monitoring compliance with company policies

and procedures, FDA, Customers, EEO regulations, External Regulatory bodies compliance expectation. Internal and

External audits, Process control, Validation program maintenance, Maintain and organize Design Master/History

Records (DMR, DHR) Prepare and submit to US FDA pre market submissions (510K), licensing and communication

up to date on daily basis. Review global regulations, guidelines and acts as compliance resource, Train and qualify

work employees in their job duties. Manage medical device design and development project with clients and customers

as a team member in a cross functional environment.

Underwriters Laboratories, Inc. Quality Registration Service

Quality Management System & Product certification

Lead auditor/Client Manager 1998- 2002 (Full time)

Lead Quality Management system Auditor for third party assessments (ISO 9001, ISO 13485, TL 9000) responsible

for making all necessary planning arrangement, including preparation of audit plans and interface with clients to

conduct Pre-assessment, Initial assessments, continual assessment visit or as needed special assessments, responsible

for gathering the audit team and provide feedback on their assignments before during team audit, review the

assessment planning matrix and verify the scope of assessment with client prior to execution of the audit. conduct the

audit, initiate the opening sessions and closing session prepare and finalized the audit report, documenting and

explaining client’s the Non conformances, (minor or major and opportunities of improvements), tracking and follow

up with client on all non-conformances corrective. Review Client’s Quality Management System documents, policies

and procedures to qualify them per scheme specific rules and requirements. Risk assessments and Clinical trial data

analysis,

3M Specialty Optical Fibers, West Haven CT

Designer Manufacturer Fiber Optics, also sub contractor manufacturer of Medical Devices

ISO 9001/ISO13485 Registered Company

Manager Quality, 1994-1998 (Full time)

Team leader and facilitator for Quality Management system, Conducted the training seminars to introduce the Quality

Management system process, Selected acquired and installed document control software package on the server,

conducted internal audits and documented non conformances in corrective & Preventive action data base, followed by

resolution of the non-conformances using 8D process. Conducted supplier qualification audits, surveillance audits and

managed corrective & preventive action follow up process. Responsible for creating a Quality information system,

data analysis to determine root cause of the non-conformances using Design of experiment (DOE) approach to rectify

the non-conformances in process and product. Developed advanced Quality planning tools (AQAP) for new medical

devices and other application of Fiber Optics.. Used Design and process Mode and effect Analysis tools (FMEA) to

determine the degree of risk associated with the product design or process. Production Part Approval process

documentation and Plans (PPAP) for submission to clients. Responsible for assessments for name brand loyalty,

analyzed consumer satisfaction surveys, and prepared the action plans to address tends in the survey data analysis.

Hobbies & Interests:

Reading about World Cultures, current affairs etc

Professional Societies:

Senior Member: American Society for Quality

RAB/QSA affiliation

References Available upon request

Foreign Languages:

German, Urdu, Hindi, Punjabi

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