*** * ***** ******, ***** Falls SD ***** 507-***-**** acqsaf@r.postjobfree.com

Steve Martin

Summary

A highly skilled Quality Engineering Manager and Safety Manager with a strong background in lean manufacturing quality. Results-oriented, high energy individual who has demonstrated a record of accomplishments in the medical field, marketing and lean quality manufacturing. Proven abilities in the medical field as an O.R. Physician’s Assistant, First Surgical Assistant and Paramedic. Demonstrated leadership in developing strategic marketing campaigns and driving down the cost of quality in the manufacturing field. Focused on success and consistently delivering strong bottom-line results. Persuasive and personable, with the ability to effectively communicate and motivate individuals at all organizational levels. Major strengths include leadership, planning, organization, cost reduction and problem resolution.

Professional Experience

June 2014 – June 2015 TSE Jackson, Mn

Quality Manager:

Manager of a quality engineering team dedicated to delivering defect free product to our customers. Reporting to the domestic and international director of quality.

Manager of MRB team: (in 9 months my team reduced NCMR’s from 243 to 7) this was a cost reduction of $263,000.00. The control of NCMR’s had been stagnant for 5 years.

Manager of incoming inspection: Through Kaizan events (implemented the use of a Keyence measuring tool) my team was able to reduce backlog parts inspection from 260 hrs to 0 hrs backlog which had been sustained for several months.(backlog parts value exceeded $100,000.00)

Manager of site supplier quality: Was able to reduce the amount of outstanding SCAR’s from 13 to 3 within a 12 month time frame. This was accomplished by: promoting and training our suppliers in the use of SPC and continuous improvement techniques at supplier locations to help them reduce variability and improve process control. (through this activity we were able to have more material received in (dock to stock) and reduce AQL inspection levels on other incoming material) Directed surveillance audits, supplier assessment/selection evaluations, continual support, and SCAR generation throughout satisfactory closeout.

Site CAPA Manager: In 1 year my quality team was able to reduce the number of outstanding internal/external corrective actions (past 90-120 days) from 18 to 4. Our team was also able to reduce root cause investigation and implementation phases from 90-120 days to less than 30 days. (not including verification of effectiveness)

QMS site Manager: assured continuous compliance to external industry standards/Legislation/Regulations: (ISO, FDA. RoHS, UL, REACH, and other international directives and referendums.

July 2012-June 2014 Amesbury/Truth Sioux Falls

Sr Supplier Quality Engineer:

Lead a team dedicated to running a lean/profitable business by:

a. Improving existing supplier performance engaging hands on techniques

b. Identifying new partner selection

Promoted the use of SPC and continuous improvement techniques at supplier locations to help them reduce variability and improve process control

Served as the technical liaison between suppliers and various design functions to ensure that purchased components met customer demands

Established an effective supplier evaluation system and educated the supplier organization to reflect the suppliers overall contribution to the company

Implemented and managed supplier rating systems reporting, and improvement activities

Experience working with both international and domestic suppliers

Served as an escalation point to ensure that critical supplier quality issues were resolved in a timely manner through the implementation of supplier CAPA’s

Directed (hands on) periodic supplier audits to ensure ongoing suitability of supplier systems to meet company business needs

Managed ISO 9001 system for on-going compliance and effectiveness

Managed quality department personnel

June 2011-April 2012

GEOTEK

Stewartville, MN

Quality Manager/Safety Manager:

Responsible for creation and publication of an ISO 9001:2008 compliant Quality Management System

Responsible for creation and publication of ISO compliant Quality Manual, complementing procedures and forms

Responsible for all document control associated with ISO 9001-2008

Responsible for leading Executive Quality Steering Committee, weekly meetings reporting directly to the company CEO

Responsible for identifying and training an Internal Audit Team for ISO 9001:2008 compliancy

Team leader for CAPA management site CAPA Manager)

Responsible for onsite supplier audits and incoming inspections on an international level

Responsible for approving (document control) of all manufacturing floor work instructions and revision changes

Responsible for training for GD&T inspection & reporting

Chairperson of the Safety Committee

Responsible for overseeing all aspects of plant and co-worker safety activities on a daily, weekly and monthly basis

Chairperson of the Emergency Response Team

Developed and implemented continuing education program for the Emergency Response Team

Responsible for revision of GEOTEK safety manual guidelines to meet all current OSHA standards

Planned and organized first plant fire and severe weather safety drills

May 2004-May 2010

Benchmark Electronics, Inc.

Rochester, MN

SR Quality Engineer:

Team Leader Six Sigma Black Belt/Lean Manufacturing steering committee

Team Leader Lean Six Sigma (process improvement team) using statistical process control (SPC) and other Six Sigma tools

Kaizan Blitz Team Leader

CAPA Manager for evaluation of root cause for assigned CAPA’s and implemented corrective action plans

Focal point for all customer quality issues to resolution (CAPA closure) within my customer scope

Responsible for publishing/reviewing validation documents for assigned medical (QSR) customers

Team Leader for qualification/validation/peer reviews (IQ,OQ,PQ) for medical device (QSR)(I.T.A.R.)NPI product

Team Leader (lead internal auditor) for FDA audits (ISO 13485)

Team Leader for all supplier quality and inspect issues on an international level including onsite customer audits

Chairman responsible for monthly site quality meetings (metrics) to direct reports

Team Leader for site Quality Alert/Escape Prevention committee

Team Leader for QSR (medical device & PCBA) process improvement committee

Responsible for driving/auditing engineering team in root cause investigations/corrective action plans (CARS,SCARS,MRB)

Team Leader for 1st article inspections for my business units Medtronic & Boston Scientific

Team Leader for GD&T & GAGE R&R inspections/studies

Responsible for auditing/monitoring all (QSR/ITAR) validation builds

Responsible for reviewing and approving/auditing all engineering (assembly releases/work instructions) (QSR) and (ITAR) PCO’s ECO’s and sustaining tasks

Evaluation for daily/weekly/monthly quality reporting for assigned customers (Abbott, Boston Scientific, Medtronic, Cray Super Computers, Coherent, SGI and Seagate)

Evaluator for all Material Readiness Reviews (MMR) for first time NPI production builds

ISO 9001:2008 (ISO:13485)p internal audit Team Leader

Leader of Benchmark Emergency Response Team

1999-2003

Celestica

Rochester, MN

Quality Engineer:

Team Leader for the quality aspect of high-end printed circuit boards for IBM systems worldwide

Team Leader for the Lean Process Development Committee

Spearheaded engineering (Lean Team) in Kaizan Blitz implementation, with a $2m cost reduction to manufacturing in the first year

Developed/implemented a repair/scrap quality tracking system for each manager’s machine lines (SMT) that held each manager accountable for quality metrics/revenue on a monthly basis, with a $1.5m cost reduction to manufacturing in the first year

Team Leader for Six Sigma statistical process control studies (SPC) over 6 super SMT machine lines (SMT)

ISO-9001:2008 internal audit Team Leader

1997-1999

IBM

Rochester, MN

Marketing AS/400- RS/6000

Served as a Team Leader in support of the AS/400-RS-6000 systems

Generated $200,000+ per quarter in support revenue for the AS/400-RS/6000 systems

Developed strong customer loyalty by offering cost effective resolutions to their support needs

Previous Experience

EMT/Paramedic Instructor – Riverland Technical College, Rochester MN. Instructed EMT’s volunteer firefighters and First Responders in the following courses: Paramedic, CPR, Advanced cardiac Life Support instructor, First Responder, EMT, Pharmacology

Served as 1st Surgical Assistant for a group of four general/vascular surgeons. Served as a Paramedic Instructor for the Chicago Fire Department

Education

University of Wisconsin

Madison, WI

Bachelor of Science Degree – Medical Arts – Internship as a Surgical Physician’s Assistant at the University Of Wisconsin Medical Center. (Trauma specialty)

Certification

IPC-A-600

IPC-610

Level 3 hand Soldering/J-Standard

Gold Tab Inspections

Advanced Quality Basics

LGA Inspection

ISO-9001:2008

ISO-14001

ISO-13485 auditor

ISO-17025 calibration trainer

SFDM Basic Training

Excel Intermediate

ITAR certified

ISO-13485

IQ,OQ,PQ,CGMP

GD&T

IQ,OQ,PQ

CPK

Gage R&R

Prior Medical Training

Physician Assistant O.R. Training, WS Bump Medical Group, Rhinelander, WI, Joseph Bodensteiner, MD,F.A.C.A

Advanced Cardiac Life Support Instructor/trainer, Methodist Hospital, Madison, WI, Mark Olsky, MD, Director of Cardiology

Paramedic Training, Silver Cross Hospital, Joliet, IL Ahmed Tour, MD, Program Director

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