Franklyn Adams

213-***-**** ● ad1tyy@r.postjobfree.com ● linkedin.com/franklyn-adamsmailto:ad1tyy@r.postjobfree.com

PRINCIPAL QUALITY ENGINEER

Key competencies include:

Corrective & Preventive Actions (CAPA)

Non-Conforming Material Reports (NCMR)

Risk Analysis (ISO 14971)

Statistical Techniques

Receiving & Inspection

Material Review Board (MRB)

Test Method Validations

Statistical Process Control (SPC)

EXPERIENCE

BRIDGING CONSULTING LLC, Los Angeles, CA 2023-present

Consultant

Reviewing protocols for real time/accelerated aging, and Process Qualification (PQ) protocols for FDA submission by overseas vendor.

SONENDO, INC., Laguna Hills, CA 2022-2023

Principal Quality Engineer

Managed Receiving & Inspection and Calibration departments.

Introduced paperless Adobe system to replace paper-based system for incoming inspection, reducing GDP errors on inspection forms by 20%. Added linked inspection equipment (calipers and drop gauges) to department tooling decreasing inspection time by 20%.

Completed two CAPAs on labeling errors in response to field corrective action; managed multiple CAPAs on cleanroom certification and training.

Conducted Statistics training on distributions, outlier tests, and Johnson Transformation.

Created SOP for Test Method Validations and provided training for engineers/ managers on non-destructive and destructive test methods.

Responded to MDSAP audit finding by updated Hazard Analysis documents for compliance to 2019 version of ISO 14971.

Initiated SPC charting for apical testing using Individual-Moving Range (I-MR) charts to provide quicker response time to decreases in production yield at final test.

Led Material Review Board (MRB) for weekly NCMR updates and quarterly trend charting of aging NCMR’s.

CONFLUENT MEDICAL TECH., Laguna Niguel, CA 2018-2022

Principal Quality Engineer

Achieved compliance with MDR, EU/POP, Proposition 65, latex, and nanoparticle standard requirements by documenting Materials of Concern.

Created Validation Strategies, OQ/PQ reports, pFMEA’s, and Inspection Plans for multiple catheter and balloon projects.

Initiated paperless data collection system using Servoy at the Orange County site, which allowed for easy transfer to Costa Rica site – previous projects had used dissimilar data bases.

Upgraded PC-based replacement calibration software (GAGEpack) to server-based platform for Orange County site allowing for site to check calibration status on line.

Completed Black Belt project reducing Out of Box Failure Rate for balloon forming and catheter test equipment from 2 complaints per month to less than per month.

MEDTRONIC – DIABETES, Northridge, CA 2002-2018

Senior Principal Quality Engineer

Remediated risk analyses per ISO 14971 for multiple insulin pumps and glucose sensor transmitters.

Created and updated Hazard Analyses for Paradigm and Next Generation Pumps

Managed Senior Quality Engineers in support of insulin pump production, new product launches.

Led three CAPA’s for Next Generation Pump including insulin pump alarming during airplane descent and detached retainer ring for insulin reservoir which lead to field recall.

Reviewed and approved vendor qualification documents (OQ/PQ, TMV) for multiple insulin pump projects.

Led four Continuous Improvement project teams, one of which Decreased capacitor damage during harvest and failure analysis by 30%.

Instituted replacement for super capacitor on Paradigm insulin pump which decreased field failure rate by 10 pump returns per month.

Decreased failure rate for adhesive dispensing process resulting in annual savings of $40,000.

Won Star of Excellence Award for two critical projects: Response to Thailand Flood – brought alternative PCBA and capacitor vendors on line, which prevented a line shut down due to lack of components; Project Paperless – qualified a combined new and refurbished production line, resulting in an annual savings of $1.0M.

JOHNSON & JOHNSON – CORDIS, Warren, NJ & Fremont, CA 1997-2002

Production Supervisor/Quality Engineer

Validated test methods for visual examination of nitinol stents after electro-polishing.

Qualified new test method for non-contact equipment to measured nitinol transition temperature (Af).

Created major revisions of visual inspection standards for post-electro-polishing of stents and vena cava filters.

Production Supervisor: Supervised the activities of 40 technicians (day and swing shifts). Successfully managed the concurrent introduction of a vena cava filter and several nitinol stents.

Taught statistics courses introducing Minitab to Fremont site. Topics included t-test, Kolmogorov-Smirnov goodness-of-fit test, and screening DOE’s.

Performed software validation (creation of SRS, Validation protocols and reports) for the MRP database modules used to track production and quality parameters for nitinol stent and vena cava product lines.

GUIDANT – VASCULAR: Santa Clara, CA, 1994-1997

Test Lab Supervisor/ Project Leader

Reliability Test Lab Supervisor: Directed seven technicians in submission and aging testing to support PMA(s) for multiple coronary catheter and stent products. Decreased lab turnaround by 40% by automating data collection, improving test method standardization, increased test method repeatability and reproducibility, and streamlining qualification/validation protocols.

Project Leader for Laboratory Information Management System (LIMS): Led the rollout of an Oracle database with a Visual Basic front end for the Reliability test lab

PRINTRONIX: Irvine, CA,

Quality Engineer, 1989-1993

EDUCATION

MS, Quality Assurance, California State University – Dominguez Hills

M.B.A., Engineering Technology, City University

BS, Electrical Engineering, University of Arizona

AWARDS & CERTIFICATIONS ATTAINED

Black Belt (IISE/USE, USC)

oProject: Decreased Out of Box Failures for Balloon Forming Machines and Burst Testers by Factor of 4

Green Belt (Medtronic)

oProjects:

Decrease Internal Failures for Adhesive Dispensing Operation

Paperless Insulin Pump combined production and repair line

Star of Excellence (Medtronic) 2007 & 2012

Certified Quality Engineer – ASQ

Certified Reliability Engineer – ASQ

Contact this candidate