Quality Engineer Assurance

SAEED MARZVAAN

Saeed Marzvaan *****.********@*********.*** 714-***-**** (M)

Experienced Quality Engineer with background in:

Quality Department Management

Hands on Testing and Materials Engineering, and Training.

Production Quality Assurance

Trouble Shooting, RCA/ CAPA / SCAR, while identifying future production Quality improvements.

Design review by means of QA approval of the V&V. (ISO 14971)

Product Transfer Validation (via Master validation plan) writing / managing

Supplier Evaluation and Management including Receiving Inspection Plan writing / Testing / Measuring.

New Product Quality Management from R&D to Inventory.

Education:

Masters of Materials Science from UTA

Bachelor of Metallurgical Engineering From AMUT

Key Competencies: Medical Devices, & Pharma

Certified ISO 9001/13485 Auditor/Trainer

FDA-QSR/ ISO 13485- 2022 re-certified Auditor

Six Sigma Green Belt (Recertified 2022)

Business Strategy/Innovation team member

Automotive/PPAP/APQP/FMEA

Statistical Analysis/ MS office/ CAD

Managing MRB, NCRs, RCA, implementing CAPA

USA & Far East Supplier selection/ contract

Writing & Implementation

Certified Supplier Auditor, Managing SCARs

Completed Parker Hannifin, boot camp & BB training

Strong GD&T, ANSI 14.5, SPC. Minitab

Project Management.

Problem solving, via 8-D, Ishikawa fish bone, PDCA Hands on ISO 14971 Risk analysis & management.

Work with Automotive Customers on writing & implementing proposals for /PPAP/APQP/ pFMEA.

Technology Transfer from Japan to USA. Proposal of Master validation Plans, conducting, IQ-OQ-PQ for Med. Devices as well as sustaining c GMP

Coating, plating, Induction Weld. Metallurgical testing

PROFESSIONAL EXPERIENCES

SirTex Medical Product Category: Pharma, New Drug Aug 2023 – April 2025

For liver cancer: Y-90 Resin microsphere, Sirsphere, & Siros for selective radiation therapy for Cancer.

For hemorrhage Prevention: LAVA Liquid Embolic System for peripheral vascular hemorrhage.

Production Quality Manager

SirTex Medical Product Category: Pharma, New Drug (LAVA) for hemorrhage Prevention: LAVA Liquid Embolic System for peripheral vascular hemorrhage repair. Developed Production SOP, Testing, Rec. Inspections & WI for this new hemorrhage Prevention drug, LAVA Liquid Embolic System that is introduced to patient peripheral vascular to stop hemorrhage.

MICROVENTION / Terumo, Aliso Viejo, CA June 2021 – April 2023

A Terumo Neuro medical devices company producer of the advance Neurovascular solutions (such as special catheters) for minimally invasive surgeries and preventions for the brain aneurysms, Stroke, and more.

Senior NPD, Supplier Quality Engineer

Cooperated with R&D & Manufacturing teams for all new products with sFMEA development.

Participated in & managed MRB Meetings for on-time completion of all issued supplier-related NCRs. Initiated, finalized, & issued SCARs successfully.

Worked with suppliers & internal departments for any supplier-quality related issues

Performed Supplier audits, mostly new suppliers (they require team audits by QE & subject SME)

BSi Group (Notified Body), CA

Quality Management System Assessor Jan. 2021 – March 2021

Hired as QMS auditor & completed their vigorous systems training including but not limited to: ISO 9000, ISO 9001, ISO 13485, ISO 14971, ISO 17021, Method of Auditing and format used.

Freelance Consulting for ISO, & QMS implementation for small companies. Apr. 2018 – Dec. 2020

Parker Hannifin, MSD division, CA

Supplier of polymers & Plastic injection and rubber Molding to Medical device companies Sept. 2013 – June 2017

Quality Manager of the Medical System Division (all 5 Business Units), responsibility for 5 business sites.

Implemented QMS for all 5 sites, in collaboration with each site

Responsible for the financial Metrics of the Quality Dept. KPI implementation throughout the division and meet corporate goals and objectives for the division.

Under the supervision of the Division GM, and collaboration with each Business Unit Manager & Quality Mgr. by implemented Parker Management system & daily meetings, within the last 2 1/2 years, I was the lead COPQ reduction of what was accepted as normally produced scraps from $2.6 Mil at FY2013 to $1.4 Mil for FY2015.

Managed the relocation of quality departments of 4 Business units, planned and implemented all V&V required by our customers. This included managing all critical customer communications.

Participated in two successful FDA audits in collaboration with local BUMs & QMs by early review of the documentation, Action Items planning, and completing those action items that we identified.

Established and collaborated in Material Supplier Audits, Service Suppliers, and Internal Audits. Believer in detailed & precise communications with all parties involved & with their support to resolve any business issues.

Completed Parker Black belt training classes and Tests (4 weeks). I was the key member of our Division and GM team for the advancement of MSD future plans and New Business development as I worked closely with all our customers (internal & external). The last project was hands-on transferring and combining Quality divisions of 4 business units from the USA to Mexico and qualifying all products for all medical device customers at the Mexico location.

Memry Corporation, (a NiTi) producer Jan. 2013-Sept. 2013

Part of Resonetics Company, Medical device Supplier and contractor for Class I & II, III, Nitinol

Part of Resonetics Company, a medical device Supplier and contractor for Class I & II, III, Nitinol.

Director of Quality

Implemented and improved the Quality & Regulatory System for the two company locations (CA & CT) to meet FDA 21 CFR part 820 & relate to Registered ISO13485 QMS.

Connecticut Unit (the HQ) was the producer of all the wires. California Unit produced the tubes and sheets.

I had 5 direct reports (two QA Managers, two document control specialists, one Quality Engineer, and 14 indirect QA Techs. They were trained and conducted internal audits under my supervision. Two MFG. Engineers were trained to audit QA dept.

Memry Products are various Peripheral Medical devices made of Shape Memory alloy (Nitinol)

SYNTHES USA, HQ in West Chester, PA (NPD location LA/CA) Sept. 2009 – Dec. 2012

Synthes is an international Orthopedic device manufacturer (Medical device Class I & II, III)

Due Diligence Quality Manager.

Prepared all New Product Development Quality documents, performed Statistical Data Analysis, Quality SOPs & WIs. for the production at the West Coast Facility in Los Angeles, CA.

Performed selected West Coast Supplier Quality Audits as assigned by my manager.

Implemented & documented the quality-related tests & evaluated Sterilization Documents.

The final product was Market Ready CMF (Cranial Maxilla Facial) implants for Eyes, Chicks, and Chin bones.

Documented & finalized all the QA related process steps from R&D, DQ, Risk Analysis, plus the manufacturing V&V to meet FDA Requirements. (Details are confidential).

Establish & Approval of IQ, OQ, PQ, DFMEA & PFMEA, along with Manufacturing Engineer.

Updated the Design FMEA for Design transfer, DQP, PQP, Process mapping, including Sterilization process and data. partners

Also, auditing the selected Suppliers for the Synthes South West territory. Wrote the procurement specs. for the raw materials.

Oversaw all receiving inspection results before approval, with the purchasing agent partner.

Evaluation of the Quality System and Technical aspects of prospective companies/products. I was trained, & certified as an ISO13485 Lead Auditor, Risk management, and FDA 820 CFR 21 regulatory compliance.

ORMCO ORTHODONTIC (Medical device Class I & II), Glendora, CA 2004 – 2009

Ormco is a manufacturer of Orthodontics Devices including wires and brackets.

Principal Engineer

I was hired to manage “Technology Transfer of Titanium Injection Molding” from Japan to the USA, with a $2 million budget. Completed the project one month ahead of the established timeline and under the budget.

Conceptualized & mapped the project. Assigned a budget for each step with the collaboration of our Japanese partner. Upon identifying the team members and their responsibilities,

Mapped the project steps with help from Ormco team. identified the machinery & manufacturers & raw materials suppliers. Defined the timelines and executed the project. The result was the completion of the project within the targeted timeframe and under the allocated budget.

During the project implementation, I scheduled weekly meetings with management and kept them informed of all progress and any issues. Documented details of Ti MIM technology in Japan, documented process specifications, and wrote Quality tests (IQ-OQ-PQ) and Process/methods for our US location. Also managed Ormco R&D laboratory team as R&D function. (Research & Development- Materials & Process Development- support Mfg. & QA) in between Tech. Transfer open time. • Created a new alloy and Mfg. method to improve the existing production part quality by 15%, and reduced cost by over 50%.

Supervised a staff of three R&D technicians, and handled Health R&D Safety & Heath protocol.

Developed Study Test Procedures, Std. Protocol format, R&D test result archiving, and retrieval.

Actively supported Quality Functions and System (ISO 13485/CFR820) such as MRB meetings, and CAPA process development for the R&D by providing recommendations/solutions. Performed risk analysis and planned Supplier audits and management for R&D.

Improved the manufacturing process by listening to VOC, risk analysis, Pareto charts, and Statistical Analysis.

Supervised the NiTi wire production Dept.

METAL POWDER PRODUCTS COMPANY, Anaheim, CA 1989 – 2004

(Manufacturer of powder metal products for Industrial & Automotive purposes)

Quality Manager - Engineering Manager

Managed and trained a staff of 14 (4 Quality – 3 Engineers – 3 Maintenance & 4 Tooling). Contributed as a management team member to grow Annual Sales from $4 M to $13.5 M. Implemented ISO 9001 QMS in the Company. Produced lock parts for Trucks and Chrysler Mini Vans. Completed Educational courses & won several Awards of Excellence.

PROFESSIONAL DEVELOPMENT

Pre-MBA courses, University of Texas, TX Certification of PMT level “I” and PMT “II” from MPIF

Toyota Business Philosophy (Lean) customized for US: KPI, VRK, PD, & DM.

TQM, Lean Manufacturing, Kaizen, DOE

Completed courses in Quality Management and ISO systems implementation, six Sigma Green Belt, completed Parker Hannifin Black Belt training, Quality Auditor, ISO Coordinator, ISO 9001, ISO14971, ISO13485, ISO17021on/ Supplier audit & management / cross-functional & cross organizational team approach, Risk Analysis, Design FMEA, Process FMEA, and Supplier FMEA.

PUBLICATIONS

“Improved Gas removal process for Aluminum Silicon Eutectic alloy during Die Casting”

“Effect of rear Earth elements on properties of Thermo-Electric materials”

“Application of P/M Stainless Steel in place of competitive manufacturing processes”

TECHNICAL

MS Office Suite, Sigma Plot, Minitab STAT software, Auto CAD & SolidWorks, SAP

Active in creating a New Mfg. site for Parker Hannifin in Mexico

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