SUMMARY:

• Over ten years of Quality Assurance/Quality Engineering experience in various manufacturing companies with products & services for medical, commercial, military, aerospace, automotive, electronics, semi conductor industries. Experience with application of quality tools such as Advance Product Quality Planning (APQP), Failure Modes Effect Analysis (FMEA), Design of Experiments (DOE), SPC, root cause analysis, CAPA (corrective action & preventive actions), supplier corrective actions with 8 D corrective action approach (SCARs), supplier audits, MRB/NCMR dispositions, process capability studies, Six - Sigma methodology, Quality Control Plans, lean six sigma manufacturing, value stream mapping, design validation, process validations (IP, OQ, PQ), compliance with FAA & medical device directives & FDA CFR 21 requirements, good manufacturing practices (GMP), JIT, 5 S and error/mistake proofing.
• Experience with implementation of various quality systems leading to in ISO 9001, QS 9000, AS 9100 & ISO 13485. Experience with clean room and sterilization requirements, quality procedures, supplier qualification & development, tooling & part s, IPC 610 standard, Mil Specs and continuous improvement. Experience in interfacing with customers for field failure analysis & resolution of quality problems. Have good project management, inter-personal and communication skills. Experienced in the use of SAP, Agile, Lotus notes, Microsoft Outlook, Microsoft Project. Five years experience as lead auditor auditing to MDD requirements as per ISO 13485 including Canadian & European requirements.

PROFESSIONAL EXPERIENCE:

Confidential

Senior Quality Assurance Specialist

Responsibilities:

• Developed supplier specifications for various items related to cGMP products and sent to suppliers.
• Coordinated risk assessment impact of supplier change notifications on production items and revised item specifications
• Communicated supplier change notifications to clients.
• Coordinated with IT and Purchasing & Merk/Millpore headquarters in development of critical suppliers list, annual audit list and Supplier Performance system in preparation for FDA audit.

Confidential

Supplier Quality Engineer

Responsibilities:

• Managed suppliers in support of FDA & AATB compliance requirements.
• Performed multi on-site qualification and surveillance audits within USA and foreign countries.
• Participated in Material Review Board meetings (MRB), performed root cause analysis and processed NCR (non-conforming reports) for disposition of non-conforming materials.
• Issued supplier corrective actions (SCARs) where necessary including their satisfactory closure.
• Monitored and managed Supplier performance ratings of critical type I suppliers for Irvine CA OrthoBiologics Division of SeaSpine Corporation.
• Processed new quality procedures and supported approval of corporate procedures after Sea Spine Spin off from Integra Life Sciences.
• Provided support for closure of several CAPAs and customer complaints.
• Provided support during external audits by FDA, ISO 13485 body and AATB.
• Provided support for internal audits and Management Review meetings.
• Participated in internal audits in support of effective Quality System ISO 13485.

Confidential

Quality Engineer

Responsibilities:

• Updated risk analysis documents (DFMEA, PFMEA, and AFMEA) based on CAPA findings, customer complaints, ECRs, NCRs and process changes.

Confidential, Irvine, CA

Supplier Quality Engineer

Responsibilities:

• Provided AS 9102 support to receiving inspection by getting missing documents from suppliers to minimize MWN (material withhold notice) hold time.
• Changed parts status to DI (skip lot) and PS (dock to stock for preferred suppliers) by reviewing the qualification criteria and implementing the change in mainframe database.
• Conducted PS (Preferred Supplier) and PV (Process Validation) audits on critical suppliers per schedule.
• Provided support to expedited closure of Corrective Action Requests (CARs) issued to suppliers.
• Completed special studies as required.
• Participated in Quality Clinics, Supplier CAB (Corrective Action Board), Supplier Improvement Plans (SIPs) and supplier symposium.
• Reviewed rejection tags.
• Used Solumina, E Flow, AMAPS and IBM Lotus notes version 9, Enovia & FSD share drive to complete various quality assignments.

Confidential (Redondo Beach, CA)

Validation Engineer/CAPA Coordinator

Responsibilities:

• Experienced with the compliance requirements and application of ISO 13485, CGMP & CFR 21.
• Provided support for design verification & validation.
• Implemented master validation plan including validation of equipment & processes related to chemical formulation processes involving microbiological growth for Controls Mfg. and Electrophoresis divisions using IQ, OQ & PQ methodology.
• Monitored customer complaints to review adverse trending for CAPA considerations.
• As CAPA coordinator, coordinated & expedited closure of CAPAs in a timely manner.
• Supported Material Review Board meetings & disposition of non-conforming materials (NCMRs).
• Provided root cause analysis & problem solving support to close CAPA, NCMRs and customer complaints for timely closure.
• Issued supplier corrective actions (SCARs) to non-performing suppliers.
• Reviewed & approved change requests & manufacturing batch records.
• Provided support to new products & R and D teams for risk analysis/assessment and validations.
• Provided support during internal and external audits.
• Monitored & managed risk minimizing during product realization.
• Reviewed adequacy & accuracy of mfg. batch records (DHR) and change requests.
• Processed standard operating procedures (SOPs) and Preventive Maintenance (PM) documents.
• Participated in meetings for Management Review, Quality Review Board (QRB) and NCMRs.
• Fulfill the responsibilities of QC manager & QARA Director during their absence.
• As QA/RA designee, reviewed and approved “Declaration of Conformity” letters for European Directive 98/79/EC and product “ of Analysis” for products shipped to customers.
• Performed CAPA coordination.
• Dispositioned non-conforming products, performed root cause analysis.
• Monitored Supplier performance, issued SCARs as required.
• Processed and received approval on Quality Agreements from critical Suppliers.
• Maintained annual Supplier Audit Schedule for critical suppliers and their updated s.
• Participated in internal audits in support of effective Quality System ISO 13485.

Confidential (Irvine, CA)

Sr. Supplier Quality Engineer

Responsibilities:

• Developed suppliers through the use of lean six sigma tools and value steam mapping.
• Improved manufacturability by acting as liaison between suppliers & engineers for review of tolerances, specifications, workmanship standards, approval of pre-delivery variance (PDV) and supplier advanced action authorization act (SAAA) for drawing change requests.
• Managed the MRB activity including disposition of non-conforming materials.
• Managed Corrective Action & Preventive action (CAPA) system.
• Resolved customer quality complaints related to suppliers.
• Issued supplier corrective actions (SCARs) & followed up on effective SCAR closures
• Conducted qualification audits for Rockwell EMS suppliers at Irvine, CA facility.
• Reviewed supplier quality performance & score cards on a monthly basis & implemented supplier development &/or exit strategies as necessary.
• Issued notices to non-performing suppliers to establish & implement performance improvement plans (PIP) to meet defective parts per million (DPPM) & on time delivery (OTD) goals.
• Established Confidential purchasing quality codes & quality management (QM) levels for purchased parts.
• Participated in “critical suppliers early engagement” meetings in design development
• Participated in PFMEA and lean six sigma meetings.
• Performed source inspections to support just in time goals.
• Supported FAA (US) and EASA (European) audits.

Confidential (Irvine, CA)

Supplier Quality Engineer

Responsibilities:

• Completed process & equipment validations at Sanmina Corporation using IQ, OQ & PQ techniques.
• Provided supplier development support through lean six sigma techniques, value stream mapping, error proofing to non performing suppliers to help them meet supplier metrics for quality.
• Conducted on site audits (qualification & surveillance) to ISO 13485 requirements for new supplier approvals & existing strategic suppliers.
• Completed supplier performance score cards and helped suppliers to improve their performance.
• Issued and closed supplier corrective & preventive action requests.
• Dispositioned nonconforming materials as member of MRB/NCMR team.
• Presented supplier management matrix in CAPA (Corrective and preventive action) meetings.
• Resolved customer complaints related to supplier quality.
• Participated in quarterly business review meetings with strategic suppliers.
• Interfaced with Engineers & suppliers to resolve producibility issues.
• Completed validation of supplier equipment and processes using installation qualification (IQ), operational qualification (OQ) and process qualification (PQ) methodology.
• Participated in internal audits in support of effective Quality System ISO 9001.

Confidential (Yorba Linda, CA)

Supplier Quality Engineer

Responsibilities:

• Managed supplier quality performance and score cards.
• Conducted supplier qualification audits for approval.
• Issued supplier corrective actions (SCARs).
• Participated in Material Review Board (MRB) for disposition of nonconforming products.
• Visited key suppliers for development & implementation of road map towards achieving satisfactory quality matrix requirements.
• Conducted root cause analysis for resolving supplier related quality issues identified internally and those identified through customer complaints/returns using CAPA.
• Implemented skip lot & part program to reduce receiving inspection workload.
• Reduced manufacturing costs & facilitated producibility by acting as a liaison for suppliers & Confidential Engineers for implementing supplier improvement suggestions, revision of drawings, BOM and design changes.
• Participated in internal audits in support of effective Quality System ISO 9001.

Confidential

Senior Supplier Quality Engineer

Responsibilities:

• As quality systems consultant, conducted quality systems gap analysis & eliminated deficiencies.
• Helped the company get re- in ISO 9001:2000 and AS 9100
• Conducted supplier qualification audits, surveillance audits.
• Issued supplier corrective actions as necessary.
• Managed MRB process, participated in Root Cause Analysis & 8 D corrective actions.
• Provided support to Supply Chain Management for qualification of new low cost suppliers.
• Participated in corporate monthly supplier quality review for key suppliers.
• Improved supplier quality by providing and implementing quality tools such as Process Mapping, PFMEA, process validation, Control Plans, error proofing, gage R & R and SPC
• Established dock- to- stock & Skip lot program resulting in reduced inspection.
• Provided QE support for development, testing, validation & release of new products.
• Managed Supplier performance database including Supplier qualification, development, supplier audits & corrective actions, supplier, supplier consolidation and support for outsourcing.
• Conducted process capability studies for tooling qualification & part qualification.
• Provided timely resolution of customer complaints & problems through root cause analysis and 8D corrective actions.
• Participated in change control board (CCB) & deviation meetings.
• Provided internal audit support for Quality System

Confidential (Lake Forest, CA)

Supplier Quality Engineer

Responsibilities:

• Participated in design review meetings to insure manufacturing & inspection capability.
• Provided & support for QS 9000 including internal auditing & corrective actions.
• Provided QE support for new product development, validation & testing.
• Established Quality Control Plans and PFMEA (Process Failure Mode Effects Analysis).
• Provided support for PPAP (Production Parts Approval Process) and APQP (Advanced Product Quality Planning) requirements.
• Conducted process capability studies to certify processes & tools.
• Implemented SPC and provided FMEA, Gage R & R at suppliers & within the company.
• Provided QE support for supplier development, conducted vendor surveys and supplier audits.
• Resolved customer quality complaints through root cause analysis, interim containment actions & implementation of permanent corrective actions.
• Reduced rework, scrap and waste by implementing just in time, 5 Ss, FMEA, SPC & process optimizing.

Confidential (Tustin, CA)

Manager of Quality Assurance & Mfg. Engrg.

Responsibilities:

• Supervised staff of Quality Engineers, Manufacturing Engineers, Inspectors & Technicians as Manager of Quality Assurance & Mfg. Engineering.
• Developed Quality Plan and implemented quantifiable & measurable quality metrics and objectives for the staff.
• Validated processes and product specifications by designing performance tests for new products.
• Provided new product support by design verification and validation.
• Monitored supplier performance, conducted capability studies, performed supplier audits
• As ISO 9001 management rep, presented monthly reports to the staff for key quality indicators such as customer complaints, open CAR s, warranty returns, supplier ratings, plant performance and internal/external audit results.
• Established quality policy, quality procedures, quality manual & provided ISO 9000 including gap analysis and elimination of deficiencies.
• Conducted internal and external audits & reported findings in the Management Review meetings.
• Improved process yields & reduced non-conformance costs through DOE & SPC implementation.
• Provided effective document control system and maintained all Quality System procedures.
• Coordinated & controlled calibration of all inspection tools & equipment.
• Participated in ECB, MRB, design, contract reviews, FMEA & Improvement Meetings.
• Participated in failure analysis & corrective action investigations (internal & at suppliers).
• Responsible for issuing corrective actions (CAR s) internally & to suppliers
• Monitored customer complaints, conducted root cause analysis, issued corrective action requests
• Issued RMAs and resolved customers complaints & problems using structured root cause analysis.

Confidential (Tustin, CA)

Mfg. Engineer & QS 9000 coordinator

Responsibilities:

• Provided manufacturing engineering support.
• Developed QA Manual and all procedures (level 1 & 2).
• Provided extensive QS 9000 & completed gap analysis for QS 9000 Quality System.
• Helped with QS 9000 in record time.

Confidential (Costa Mesa, CA)

Mfg. Engineer

Responsibilities:

• Provided Manufacturing Engineering support for design & development of new molds and injection molded parts.
• Processed all quality procedures (level 1 & 2).
• Completed gap analysis, eliminated deficiencies and provided ISO 9001 .
• Procured ISO for CIMCO in record short time.
• Improved customer satisfaction by resolving molding related problems.

Confidential (Brea, CA)

Industrial Engineer

Responsibilities:

• Provided Industrial Engineering support.
• Analyzed quality data, implemented SPC on critical characteristics & provided SPC .

Confidential (Fountain Valley, CA)

Senior Project Engineer

Responsibilities:

• Provided support for Industrial & Manufacturing Engineering responsibilities.
• Performed capital justification for various capital spending projects
• Provided SPC and implemented SPC in critical manufacturing areas.
• Participated in continuous improvement and methods improvement meetings.

Confidential (Chicago, IL)

Group Leader Industrial Engineer

Responsibilities:

• Provided Industrial Engineering support to all production departments for developing & refining work standards, improve methods & efficiency, coordinated continuous improvement program.