Mechanical Engineering Quality Assurance

PETER MENG

E-mail: *********@*****.*** Tel: 908-***-**** (C)

Address: Bridgewater, NJ 08807

EDUCATION MS - Mechanical Engineering, 1995: New Jersey Institute of Technology; Newark, NJ

(GPA 3.82)

BS - Manufacture & Mechanical Engineering; Dong Hua University, Shanghai, China CERTIFICATE QMS Internal Auditing Certificate, SPC Certificate SUMMARY Over 15~20 years of experience in engineering, including:

Strong capability to quickly get on work & solve problem under different working environment (Solid engineering background/experience & intelligent analysis apply to any type of engineering work) with approved track.

Experience of design/manufacturing process in medical device / FDA CFR 21 Part 11, 21, 210, 211, and 820, ICH /3/6/9, ISO 9001, ISO 13485, ISO 14971, cGMP/GMP or GxP environment, FMEA.

Experience from concepts to application in lean 6 sigma, PPI, Value stream, Kaizen/5S, FDA/ISO Audit, Verification & Validation, CSV, Statistics analysis – Minitab (ANOVA, DOE, and Gage R&R etc.).

QMS Experience, Internal & External (Customer & Sponsor) Audit

CAPA, Root Cause Investigation / Analysis, Mythologies of 8D, 5 Why, Fishbone Diagram, Process Diagram, Fault Tree, Casual Factor Charting, Human Error Checklist. MDR Reporting.

Incoming and Final Inspection, FAI, ECN/ECR. RoHS / REACH compliance

Non-Conformance Reporting / Review, Containment, Disposition/Material Removal, CA & SCAR, SQAR (Supplier Quality Assurance Requirement)

More than 10 years of experience in physical & thermal design, product development-Research

/Research /qualification/analysis/prototype/testing,

Design, development & localization on different generations of equipment / devices as a lead engineer. Experienced in the field of support & vendor management.

Strong technical management skills and excellent communication and teamwork skills. Demonstrate a drive & take initiative to achieve goals in a fast-paced environment. EXPERIENCE

Kenvue – Former J&J Skillman, NJ

11/23 – Present: QA engineer on over-the-counter medicines

Medicine Transportation Solution:

o Conduct thermal analysis of shipping lanes of all shipping modes for all over-the-counter medicines against PTR (Product Temperature Range)

o Assess risks in each failure mode vs. locations, seasons, shipping lanes, shipping time, shipping modes, packaging, product properties, etc. during transportation o Write thermal analysis report and assign the shipping code which defines the proper shipping mode and temperature monitoring

o Write SSR (Shipping Summary Report) to related function for approval.

CAPA – Organize & assist investigation of any non-conformance issues or related CAPAs during medicine transportation – Label issue (Label missing, information wrong, damaged, location wrong, etc.), packaging, identify findings, root causes, and provide solutions with team efforts

Transportation Supplier Qualifications – Yearly evaluation, assessment & criteria of transportation supplier qualification and requalification

Global Change Control (GCC) Deliverable Owner – Own the SSR GCC deliverable, participate in the meeting, and follow the process to close the GCC deliverable

XLSS Specification Committee – Provide review comments & feedback on XLSS specifications

Overall Transportation Solution – Involve in overall transportation models to simplify the transportation process.

Overall Support – Provide information & services to all transportation parties’ requirements. NJS Associate Bridgewater, NJ

03/22 – 11/23: Independent Quality Consultant

Conduct Internal Audit – Conduct internal audit periodically to help the company improve QMS and CAPA system.

CAPA / Audit Findings – Help the company Open & Close CAPA/SCARs, identify findings and consider solutions.

Change Control – Conduct internal audit on its change control documents, procedures and records. Provide guidance to improve the procedures and external audit findings.

QMS Gap Analysis – Help identify QMS system gaps, address fix, review Risk & CAPA SOP/WPDs

eQMS – Help company identify & install eQMS (Dot Compliance)

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QProSolution Bridgewater, NJ

03/21 – 11/23: Quality Consultant on Pharm/Biometric/Medical Devices

Auditor & FDA & other 3rd Party Audit Response Review – Data Integration, Data Security, Data Management, CSV, Quality Plan, QMS system, IT System – Deviation system, knowledge management, SPV, People match-procedure, etc.

QA Auditor (FDA/ISO/Sponsor/Customer/Supplier/Internal Audit) – IT, Quality System

(Document review/, Document control Document training review, Customer complaint, etc.), handle and respond audit, draft audit documents & execute audits, generate Audit Finding report.

Conduct Specific Audit – Per client guidelines.

CAPA/NCR/Customer Complaint – Conduct Root Causes Investigation based on FDA/Customer/Internal findings & customer complaints, assess the risk based on the impact, propose all corrective & preventative actions, and monitor effectiveness post CAPA application.

Change Control - Conduct audit on its change control documents, procedures and records. Eli Lilly (Pharmaceutical Company) Branchburg, NJ

11/21 – 03/22: Quality Consultant

FDA & other 3rd Party Audit Response Review (CSV, Quality Plan, QMS system – Deviation system, knowledge management, SPV, People-match-procedure)

Effectiveness Check on Implement of CAPA related to FDA Findings and Related Issues

(Change Control documents, procedures, and records / Manufacturing operation/Facility/Warehouse)

Whippany Actuation System (GE Aviation)-Military & Defense Whippany, NJ 03/21 – 10/21: Senior Quality Engineer

Service of Repair & Overhaul (SR&O) – Leading repaired unit (Actuator, Brakes, Gearbox, Different drives, etc.,) final quality qualification (BAE System, Lockheed Martin, Boeing, Collins, Sikorsky, etc.,)

Customer, Supplier & Internal Audit – Monthly internal audit, customer quarterly audits, suppler site process and inspection audit.

Supplier containment check – Arrange any NC containment internal/supplier stock check.

Customer Compliant and CA – Work and close on customer SCAR (8D, PFMEA, Control Plan, and Checklist) and Corrective Action (CA).

NC product disposition – Process all different cages of NC products disposition.

Document Review & Approval – All internal documents update and initiation.

Quality Metrics & Management Review – Prepare for customer per request Amcor – Medical Packaging Mt. Holly, NJ

02/21 – 03/21: Quality Consultant

CAPA – Leading manufacturing site all CAPA investigation (Root Causes) based on customer complaints, propose all preventative actions.

Customer Complaint – Respond and close customer compliant. Marotta Controls – Military & Defense Montville, NJ 07/20 – 01/21: Production & Manufacturing Engineer

Multiple types of Solenoid Valve Vibration Testing – Set up & Support Tektronix Lab vibration testing. Data acquisition, transfer, analysis.

Multiple types of Solenoid Valve Thermal Testing – Set up & Support Tektronix Lab thermal cycle testing. Data acquisition, transfer, analysis.

NCR – NCR on any anomalies of above testing, and analyze

Document - Test kit, test instruction, test data sheet, test setup diagrams

Capital Expense Project – Laser marking machine

Mirion technologies (Capintec) - Nuclear Medical Instrument Florham Park, NJ 03/20 – 06/20: Quality & Compliance Engineer, Responsible for Agency Compliance testing

InterTek Safety (IEC-60601-1, IEC-62366-1, & IEC-62304) Checklist – Smart Chamber, CRC-55t family and TLC checklist to Intertek, coordinate the response, and provide evidence to Intertek questions, coordinate & work the assignment to address gap.

Intertek EMC (IEC-60601-1-2) Checklist – Smart Chamber, CRC-55t family and TLC checklist to Intertek, coordinate the response, and provide evidence to Intertek questions, coordinate the assignment to address gap.

RoHS, REACH Compliance

Work with all component suppliers to verify RoHS 3 / REACH compliance according to Intertek requirements. Drive internal changes for RoHS / REACH requirements in Specification, drawings and PO.

b-ONE ORTHO – Orthopedics Design & Manufacture Cedar Knolls, NJ 04/19 – 03/20: Quality Engineer, Responsible for US and China Site

Quality Inspection Plan / NPI – All received production product inspection, CTQ checking and review. New product part First Article Inspection (FAI)

Change Control – Handle Change Control & QIP creation (Quality Inspection Plan)

NCR – Create NCRs and assign to engineers to investigate, segregate non-conforming products. Review/evaluate findings and justifications.

CAPA – Leading manufacturing site CAPA project of stain/rusting resolving after laser marking, and polishing.

FDA Audit & Internal Audit – Primary internal auditor – draft all internal audit documents/conduct monthly internal audit

Warehouse - Warehouse receiving and shipping

R&D Support - Design Verification and Validation/Writing SOP and WI, Packaging machine validation

Metrology Calibration – Handle outside calibration and internal calibration. Method validation

– Speed and incubator temperature, draft protocol.

Employee Training – Handling Internal employee training Education Testing Service Princeton, NJ

09/18 – 03/19: Quality Engineer, Responsible for TOEFL, GRE & AP Related Quality Issue

CAPA/FMEA – Assign CAPAs to related engineers, facilitate/review/evaluate the solutions and close the CAPA. Assess the risk of the CAPA based on the impact, escalate to management based on the high risk. Close more than 50 CAPAs and evaluate over 200 assignments.

Auditing – Document auditing, Testing paper problems generation process auditing.

PPI Project – Leading Personal Private Information (PPI) project and audition across all ETS related programs

Follett LLC – Ice Making Equipment Easton / Bethlehem, PA 11/17 – 08/18: Manufacture Quality Engineer, Responsible for 2 sites Quality Improvement - NPD/NPI & Sustaining Product.

Warranty Spending Improvement - Identify key products/components to drive failure rate down (Through all sources), help company save warranty loss 1M dollars, reliability & survivability analysis on field equipment.

CAPA Project – Lead & work with related function team on CAPA project of top 5 identified warranty spending components (Compressor, Solenoid, Auger, Auger Shaft, Bushing Housing)

Lead all New Product Parts Qualification – New product part FPPQ (Follett Purchase Part Qualification) Process – Similar to PPAP, First Article Inspection (FAI)

Pharmacy Refrigerator Validation – Review equipment validation protocol, monitor the validation process, and review the final report.

Lead all Projects PFMEA/DFMEA – New Elite Ice makers, cast auger etc.

Supplier Deliverability, SCAR & Audit – Support Supplier Quality Engineer (SQE) to analyze

& improve quality on component/part from suppliers – Compressor, Solenoid, controller, Auger, Main Housing, motor, etc.,

Develop / Verify Manufacturing Quality Plan – Similar to APQP, New product development and current product in manufacturing, checking points/in-process checking, Poka Yoke – Multiple Elite ICE makers, cast auger, etc.

Internal Audit – Conduct internal audits periodically on different departments and cells for both sites, write audit report.

Production Support – DOE project, ANOVA, process capability check (e.g. self-tapping screw power gun, torque-speed selection), design verification and validation (Pre-Pilot & Pilot) for new product launch (Elite H2110 & H1810)

Quality Support – Assign CAPA, & conduct root cause analysis with sustaining engineer. GD&T, Design reviews & Design Changes (ECO/ECR) Maintain & update all the forms and partial QA documents/procedures

Mindray (DataScope) – Medical Instrument Mahwah, NJ 07/17 – 10/17: Quality Engineer, Responsible for Medical Instrument of different generations and brands on Ultrasound, Anesthesia, Patient Monitoring, etc.

Customer Complaint - MDR reporting (FDA Compliance), Complaint Response

Root cause analysis – Complaint Investigation, CAPA.

Compliance, NCMR, FDA & Internal/Customer Audit, Product Specification Thermo Fisher Scientific (GC) Fair Lawn & Bridgewater, NJ 05/15 – 07/17: Process Quality Assurance Engineer, Responsible for 2 sites

Process Improvement – Filling line production bottle neck/issues (Filling & Packaging), productivity analysis – increase 20%, streamline the process for ACROS (PPI project), router setup and standardization, SOP/Work Instruction/review sheet/equipment setup.

Warehouse Quality – Draft, review & approve warehouse procedures & work instruction. Warehouse Nonconformance, Quarantine/disposition, NCR, MRB, and customer complaint & quality matrix. Internal, ISO & FDA audit. Supplier quality – SCAR. Warehouse traffic and efficiency improvement

Customer Compliant – Processing, coordinating responding, summarizing and presenting customer complaints daily. Complaint Review Board, Complaint Process map, SCAR response. Risk assessment (FMEA) on customer complaint.

Root Cause Analysis & CAPA – All leakers (Bottle/Keg/Pail/Drum), contamination (Local & system), label, etc.,

Validation/FAT - Bio-Water System, review/approve protocols, evaluate process & criteria, monitor execution and review final report.

Supplier Quality – OEM complaints, root cause/Risk analysis & recall/credit

Others –Batch records review and deviation approval, Sample size, Minitab/Statistics, KPI Board, maintain all the forms & update partial QA document/procedures Tekni-Plex Tri-seal – Medical Packaging Somerville, NJ 10/11 – 04/15: Lead Process Development Engineer, Quality Assurance Engineer Responsible for 3 plants Process Improvements, Somerville / Flemington / Blauvelt

Data and Root Cause Analysis (CAPA Project) – Daily evaluate/review multiple production lines data against the spec.,

Recall & Customer & Internal Audit – Information preparation, leading internal audit preparing for customer audit.

SPC - Development of Template for Production, Training operators on SPC

Projects of Capital Expense – Auto vs. Manual (2 Extruding LDPE Lines slitter), Die sizes comparison vs. scrap (Extruding Line COC & LDPE)

Process Improvement & Engineering - DOE project to Increase productivity

FAT – Dusenbery slitter Factory Acceptance Test protocol writing/executing and final report

Validation – Requested by GTC, OQ/PQ protocol/execution

Multiple New Product Trials & Material Property Study - Pre-corona treatment, VAV Haze test, thermoformability, coating cylinder sizes, Hopper Scale, extruding uniformity, Extruding line balancing (Input/output).

MUV Projects (Material Usage Variance) – Evaluation of all current mfg. processes/lines

(Extruding, laminating, & slitting) scrap factor vs. router/setting,

Others - Batch records review and deviation approval. Maintain all the forms & update partial QA document/procedures.

Danaher - Imaging Sciences International – Medical Dental X-Ray Hatfield, PA 6/11 – 10/11: V&V Engineer (Hardware Verification & Validation)

NGIO Projects (Multiple Models) - Write & Execute: Design Verification Test Protocol, Reliability & Life Test Protocol, And Environmental Design Verification Test Protocol (IEC Standard Thermal Cycling, Humidity, Atmospheric Pressure, Vibration, Shock, Solar & Heat Exposure, Rub, Disinfectants, ISTA Packaging/Distribution & etc.). NGIO Projects Protocol Execution Testing Coordination

Coordinate all verification testing including scheduling/arranging outside labs NGIO Projects Testing Fixture

Vibration Testing Fixture Design - set up AXE Testing Fixture (Life & Reliability Testing) 2/11 – 6/11: Validation / Manufacturer Engineer

Validation Projects

Identify & Verify Process/Equipment/Manufacturing Procedures for Projects of X-ray Dental Diagnostic Instrument (Expert DC/765 DC System/Tubehead). MAQUET (Former Boston Scientific) – Medical Device – Class III Wayne, NJ 10/08 – 2/11: Lead Process Development Engineer

Process & Development – Coating Process/Spray Equipment: Design, Development, Analysis, Set-up, Verification, Validation (IQ/OQ/PQ-Execution), Spray Hood Facility Validation, Cleaning validation (For cross contamination). Risk Analysis (PFMEA/DFMEA), Optimization (DOE), Yield Analysis/Improvement, Process Flow Chart.

Manufacturing - BOM & Routers setup in PDM & SAP System, Design/Process Transfer to Mfg, Yield Analysis & Improvement, Flow Work Training, NPI, Technical Support to Mfg. Incoming / Receiving Inspection Procedure w. QA & Shipping/Receiving Team. Manufacturing Issues, Preventative Action (Spraying System Nozzle Misalignment, Spraying Nozzle Clog, Spraying Mesh Cleaning, and etc.), Productivity Analysis.

Testing/Set-up/Procedure/Plan/Testing/Validate Equipment (Daily Base) - Process requirement test (Add-on), Test Procedure/Plan, Product Requirement Test (IQ, Shear, Axial stretch, Kink, Water Intrusion, SEM, Mock-up, Solubility, Mixing, Uniformity, Vendor equipment, Spray Pattern, ESD & Reduction, Airflow, Thermal Mapping, Noise & Vibration, Speed/rpm), Cross Contamination/Handling, All Hands-on Testing

Design & Analysis / Vendor Management - Spray Equipment Modification, Prototype, Testing Fixture, and Production Fixture using SolidWorks & GD&T Knowledge, Equipment Cost Analysis, Process Capability Analysis, and Statistics Analysis using Minitab, Testing Data Analysis

Document - IQ/OQ/PQ Protocol Writing & Report, Study Protocol, Specification, WI

(Manufacturing Procedure), Inspection Procedure, Notebook Study, PM (Fusion Spray Coating, Fusion Knitting, Bead Wrap, Serialization, etc.)

CAPA - Graft kink due to uneven compression (Vision system introduction into mfg. loose knit & shear bond strength caused by glue unevenness along multiple positions during spraying (Misalignment of Nozzle Issue - 3 years old issue solved).

Vendor - IVEK Vendor Nozzle Verification (Gage R&R) & Process, Equipment Loan Testing

DOE Project - Fusion Spray Process Verification, Productivity Improvement w. Optimizing Process Parameters (Pressure, Flow Rate, Standoff Distance, Rotation Speed, Drying Time and etc.). Yield Improvement Activities (Orientation Change, Chuck Hold Head Replacement, Drying Time Reduction),

Other Involvement Packaging Input - Folding Barrier for Graft), Simple PLC Interface Box

& programming, Process/Improvement/Verification: Antimicrobial/ Bio-Gate, PTEE SS Expansion, Stage II Sprayer Configuration/Deployment, R55 Anti-Static ESD Nozzle Implementation, FM ESD Graft attraction, FM Removal Equipment, Fusion/Bioline Product requirement test (Instron), Dipping Fixture, Spray Pattern Fixture, Fume Hood Airflow mapping, IVEK Nozzle Incoming Verification Process, Collagen/Silver Acetate Coating Application, Manufacture Issues (Sprayer Stop, PLC Freeze, Gear Box, Connector Broken, and etc.), PA (Nozzle Clog, Mandrel Cleaning Procedure), Vision Measurement System. Alcatel-Lucent Technologies Inc. (formerly Bell-Labs) Whippany, NJ 8/96 – 2/08: Lead Engineer for Thermal & Physical Design

Design - Manage Projects From Concept to Product Launch on Thermal Management of Wireless Base stations

Verification / Testing - Mock-Up Test on airflow and Temperature (Board/Shelf/Cabinet-System Level),

Product / Project / Involvement - OneBTS Wireless Base stations of Phase 1 ~ 5 Cutting Techniques Incorporated East Rutherford, NJ 5/96 – 7/96: Manufacture Engineer

Manufacturing Process Arrangement for Wired E. D. M. & Abrasive Waterjet Cutting. Publication: Overall, 20 publications of research papers

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