Medical Device Quality Assurance

Ali Asiaban

(***) *** - ****

E-mail: ***********@*****.***

OBJECTIVE:

To obtain a position where my knowledge and experience can contribute to enhanced customer satisfaction.

EXPERIENCE SUMMARY

• Solid track record of Quality and Reliability improvements in electronics manufacturing.

• Over twenty years of collaboration with international partners (customers and suppliers).

• Successful transfer of multiple manufacturing lines to subsidiaries and contract manufacturers.

• Working knowledge of medical manufacturing regulations (FDA CFR820,).

• Validation (IQ,OQ,PQ) of multiple Medical Device manufacturing lines internationally.

• Trained ISO 13485 lead auditor.

PROFESSIONAL EXPERIENCE:

08/10 – Present QAR Services, San Rafael CA.

Principal

Devise and implement custom solutions for clients:

• Regulation compliant (CFR 820) product development and manufacturing (GMP, GDP).

• Response to regulatory non-conformities.

• Supply chain quality enhancements including process improvement at supplier sites.

• Product design improvement plans including DFx (DFR, DFT, DFM).

• Continuous improvement of DFx based on real-time test, reliability and field data.

• Establishment of Ongoing Reliability Test (ORT) programs.

• Failure Analysis/Root Cause Analysis with feedback to Manufacturing and Design teams.

• Product cost reduction through improvements in product design, test and reliability.

• Implementation and maintenance of Corrective Action/Preventive Action CAPA systems.

• Implementation of FDA compliant manufacturing of drug delivery combination device at contract manufacturing sites.

12/07 – 07/10 FlexMedical (Flextronics), Milpitas CA.

Director of Quality & Reliability Engineering (Global Scope)

• Defined global procedures to ensure manufacturing processes meet FDA and customer requirements.

• Trained global manufacturing sites to be compliant with FDA regulations (CFR 820).

• Ensured each medical device manufacturing site Quality Management System (QMS) is compliant with regulatory (FDA) and ISO 13485 requirements.

• Assisted manufacturing sites in passing FDA and customer audits.

• Interfaced with customers to define product Quality and Reliability expectations for medical devices and components.

• Assisted in creation of product manufacturing flows to ensure customer and regulatory requirements are met.

• Trained and assisted medical device manufacturing sites in use of root cause analysis tools.

• Trained manufacturing sites on medical device containment and corrective action practices by assisting sites in resolving customer quality related complaints.

• Trained global manufacturing sites on FDA validation requirements.

• Customized production line validation protocols to be compliant with FDA and customer quality requirements at multiple sites.

• Ensured proper execution of validation protocols: Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) at medical device manufacturing sites.

• Utilized joint supplier audits with local Supplier Quality Engineering (SQE) teams as a training tool.

• Review of CAPAs , NCMRs and production line reject analyses for process improvements.

08/06 – 05/07 Fidelica Microsystems, Milpitas CA.

Director of Product & Reliability Engineering

• Defined pre-launch product architecture improvements based on market requirements.

• Deployed product design improvements through DFM & DFT.

• Implementation of material, process and product qualification systems.

• Achieved forty three percent product/process qualification cycle time reduction resulting in overall improvement in customer satisfaction measures.

• Design and implementation of reliability evaluation tools & methods.

• Design & deployment of next generation custom product testers.

• Development of film (roll to roll) incoming inspection processes.

03/06 – 08/06 Invensense Inc., Santa Clara CA.

Senior Quality Assurance Manager

• Drove customer resolution for key manufacturing issues.

• Deployed product qualification procedures addressing key customer requirements.

• Successful customer qualification of strategic manufacturing facilities.

• Resolution of customer product quality and reliability issues.

• Creation of Closed Loop Corrective Action (CLCA) system to address customer issues.

• Leading ISO 9000 certification efforts.

• Offshore vendor management (quality audits & corrective actions.)

05/04 – 02/06 Synaptics Inc., Santa Clara CA.

Quality Assurance Engineering Manager

• Support of CM site customer audits with corrective actions to customer satisfaction.

• Quality planning through in-process quality monitors, DFM & DFT to meet customer targets.

• Review & audit of Contract Manufacturer (CM) quality procedures for compliance with customer expectations.

• Enhancement of incoming & outgoing inspection procedures at CM sites to meet customer requirements.

• Failure Analysis (FA) of worldwide customer returns and implementation of containment/Corrective Actions at CM sites.

• Initiation of Corrective Action cycle with design and manufacturing teams.

• Continually updating customers through Corrective Action progress reports.

• Establishment of international QA support centers near customer manufacturing sites to reduce response time to customers.

• Ensuring CM adherence to ODM and OEM customer quality standards.

• Continuous improvement of Failure Analysis (FA) cycle times.

• Improvement of FA response time by thirty percent.

• Review and approval of customer RoHS warranty contracts.

• Verification of product adherence to RoHS.

• Approval of component suppliers based on adherence to RoHS requirements.

9/90 – 3/04 Allegro MicroSystems Inc., Worcester MA.

Senior Quality Manager [6/02 – 3/04]

• Interfacing with domestic and international customer base to address quality issues.

• Following up Failure Analysis reports with containment measures, Corrective Actions and customer updates.

• Issuing Corrective Action Requests (CAR) to internal ASIC fab and foundry partners.

• Continuously updating customers on containment and corrective actions until all issues have been addressed to customer’s satisfaction.

• Coordinating improvement efforts by cross-functional teams of internal and foundry engineers. Achieving fifty percent annual reduction in ASIC wafer fabrication DPPM.

• Collaborating with wafer fabrication, product engineering, product packaging and test teams to achieve high products quality and yield levels.

• Leading cross-functional teams of test and design engineers to assure complete test coverage.

• Standardizing in-house ASIC product qualification guidelines to meet automotive customer requirements.

• Enhancement of subcontractor manufacturing practices to match customer quality requirements.

9/90 – 3/04 Allegro MicroSystems Inc., Worcester MA.

Failure Analysis Manager [10/00 – 6/02]

Reliability Manager [4/96 – 10/00]

Reliability Lead Engineer [9/95 – 4/96]

Quality Assurance Engineer [8/92 – 9/95]

Product Engineer [9/90 – 8/92]

EDUCATION:

1998 Clark University, Worcester MA.

Master of Business Administration (MBA)

1993 Northeastern University, Boston MA.

B.S. Computer Engineering Technology

1983 GTE Sylvania Technical School, Waltham MA.

Certificate in Computer Electronics

Keywords:

Semiconductor wafer manufacturing, PCM, Wafer probe, Semiconductor packaging, IC manufacturing process optimization, SPC, FMEA, Yield enhancement, Multiple wafer fabrication foundries, Multiple packaging foundries, Supplier audit, Equipment procurement, Contract negotiation, FDA, Medical Device Manufacturing, Medical Production Line Validation (IQ, OQ,PQ), First Article Inspection Report (FAIR).

Standards: JEDEC, TS16949, ISO 9000, QS 9000, Mil Spec. 883, Mil Spec. 38535, FDA CFR820, ISO13485

Test: Mixed-signal test development, Test fixture design

Automatic Test Equipment (ATE): Fairchild, LTX, Factron, Teradyne, HP

Test Handlers: MCT, MultiTest, Sigma, WTS

Failure Analysis (FA): Curve tracer, Oscilloscope, Cross Section, X-Ray, C-SAM, Microscope, Photon Emission, SEM, FIB, EDX

Reliability: Reliability prediction, Acceleration Factor, Activation Energy, Burn-In, HTOL, HTRB, THB, HAST, MSL, Re-flow, TC, TS, GL, Autoclave, WLR, FIT, MTBF

Technology: Semiconductors, MEMS, Printed Circuit Board (PCB), High Level Assembly (HLA)

Safety Certification: UL, CSA, TUV compliance

Manufacturing: PCBA, SMT, Lead Free, “Green Partner”, RoHS Compliance

Manufacturing Locations: China, Hong Kong, Thailand, Malaysia, Philippines, Japan, Singapore, Austria, Romania, Mexico

Customer Locations: China, Taiwan, Indonesia, U.S., Japan, France, Germany, Norway, Austria

Contact this candidate