Quality Manager
Resume:
STEVEN HAVERSTICK
Carlsbad, CA. 92009
Thank you for the opportunity to review my qualifications and
accomplishments for a quality professional. I am a seasoned veteran in the
Quality/Compliance discipline. I am a highly motivated person who values
Quality, Innovation and Teamwork. As the enclosed resume indicates, my
extensive background in management of the Quality Assurance discipline
consists of several important contributions I've made which are:
My Accomplishments:
Quality / Audit principles/processes toward compliance requirements.
12 years of supervisory experience with hands-on experience.
Experience with design development to transfer into manufacturing utilizing
quality tools in design (HALT/HASS), Relex software, Process capability,
DFMEA toward PFMEA using clinical effects.
Success with solving complex problems using Corrective and Preventive
Actions utilizing risk based approach.
Written quality planning documents toward customer and compliance
requirements.
An overall team player for overall customer satisfaction of internal and
external personnel including customer support for returned material issues.
Reporting to management as a management representative while having a team
of associates within the quality discipline.
A lead auditor for ISO 9001:2003 (Business to Business) and ISO 13485:2003
(Medical Device requirements) with CDMR and MDD, PAL requirements.
Conducted auditor training toward QSIT requirements and ISO 13485:2003
Conducted supplier audits and supplier qualification requirements to
support ISO 13485:2003. Experience with Plastics, Metals and electronic
applications toward system implementation.
SUMMARY OF QUALIFICATIONS:
Quality Assurance/compliance professional with 25 years of diverse
experience in various state-of-the-art work environments. Demonstrated
excellence using technical expertise and TQM methods to analyze and resolve
complex, costly issues. I have the proven ability to take initiative and
"Lead the Team" towards positive, productive results. Self motivated,
focused and persistent.
Expertise in Quality Audits of ISO 9000 System as well as lead auditor
certification.
Management Representative for several companies.
Lead Auditor expertise with QSIT implementation.
Quality Engineering and Quality Control experience in medical device
companies.
Skilled Team Leader with background in Engineering.
Audit background for internal and external requirements.
Computer proficient with Internet, E-mail, and Microsoft applications in
both PC and MAC environment.
RELEVANT EXPERIENCE AND ACCOMPLISHMENTS
Abbott Vascular, Temecula, CA. 2006 to Present
CAPA Professional
Established processes to robust investigation principles utilizing Apollo
root cause analysis toward improvement of FDA audit findings within the
Corrective and Preventive Action process. A Rubric "standard of
excellence" was implemented for documenting CAPAs to improve quality
content for the investigations. Implementation of the Rubric was
implemented and conducted at all Abbott Vascular sites world wide.
Independent assessor for compliance responses to 3rd party audits as a
subject matter expert. Worked with Abbot Quality & Regulatory for CAPA
related compliance issues to support Abbott Vascular sites. CAPA
certifications in utilizing the CAPA process Rubric.
BSI Americas, Carlsbad, CA. 2005-2006
Client Manager, West Area
BSI is a Quality Management Systems registrar located in Reston, VA. My
clients are located in the West area, which includes, California, Oregon,
Washington, Utah, Arizona and parts of Mexico. I have qualifications for
lead auditor for ISO 9001:2000, ISO 13485:2003 including CMDCAS and MDD
requirements. I am currently training for AS 9100 requirements for
aerospace clients.
Respironics Inc, Hospital Division Carlsbad, CA. 2002-2005
Project Quality Manager, Special Projects
Responsible of all Quality activities in the acquisition of Novametrix
Medical Systems.
Lead the retrospective validation activities including implementation of
a 20 man consulting team of engineers. The negotiated contract costs were
in excess of 3 Million dollars.
Lead the effort to implement an improved Quality System toward ISO
9001:2000.
Lead the company effort to implement ISO 9001:2000 Quality System.
Conducted training for the internal auditor staff.
Lead team of QE's/QC to support transfer process/improvements from
Wallingford to Carlsbad during acquisition activities.
Lead design activities of electro-mechanical devices via
hardware/software capabilities.
IPITEK, Carlsbad, CA. 2001-2002
Quality Manager, Systems and Configuration Management
Responsible of all Quality and Configuration Management Systems for the
company reporting to the COO including inspection/test/incoming of product
requirements.
Lead the company effort to implement ISO 9001:2000 Quality System.
Management representative for 3rd party audits.
Lead teams to establish QC department for inspection requirements and
process improvements. Worked with teams to establish supplier
relationships for incoming materials including test systems chassis
development with these suppliers.
Implemented CAPA database system for improved responses and tracking.
Managed all configuration management systems (engineering and quality
system docs).
Lead design activities of electro-mechanical devices via
hardware/software capabilities.
Performed complaint analysis of returned product for corrective action
and feedback to customer regarding improvements for Transceiver/high speed
bi-directional communications.
Alaris Medical Systems, San Diego, CA. 1998-2001
Senior Quality Engineer
Performed complaint analysis of returned product for corrective action.
Provided technical support to operations by ensuring qualified capable
processes.
Prevented problems and ensured continuous improvement in the
manufacturing areas.
Responsible for overseeing failure analysis and documentation recommends
corrective action.
Lead design activities of electro-mechanical devices via
hardware/software capabilities.
REMEC Inc. (REMEC Wireless), San Diego, CA. 1997-1998
Senior QE/Manager
Employed to assist REMEC senior management in obtaining ISO 9001
certification.
Developed and Implemented Wireless Quality Assurance Procedures and
detailed Inspection Instructions for the Quality System.
Primary Engineer on Corrective Action board for product improvements.
Reviewed RMA database trends for product improvement and required
Corrective Action and reporting to Customers regarding transceiver/receiver
applications in the wireless industry.
Developed incoming procedures/process to ensure product conformance.
QE/QC representatives assisted with this implementation.
Products consisted of RF to microwave and millimeter wave frequencies,
specializing in complex, high performance point-to-point radio modules and
Outdoor Units (ODUs) with hardware/software control capabilities.
"C" Enterprises, San Marcos, CA. 1996-1997
Quality Manager
Supervised all the Quality functions consisting of receiving, in-process,
and shipping inspection personnel.
Lead internal auditor for continual compliance to ISO element requirements.
Implemented a company audit team and coordinated all corrective actions and
follow up requirements.
Titan Linkabit (subsidiary of Titan Corporation), San Diego, CA. 1996
Consultant as Quality Systems Manager
Directly reported to President of Titan Linkabit for transitioning to an
ISO environment.
Pacific Communication Sciences Inc., San Diego, CA.
Wireless telephone applications for cell/laptop communications with CDPD
technologies.
Hughes Aircraft, Fullerton, CA
Quality/Test/Design work in the DOD and covert program with Radar,
Receiver Transmitter Antenna applications in freq range 800MHz - 40GHz.
General Dynamics, Pomona, CA
Missile systems programs using design of automatic test equipment for
product acceptance.
Rockwell International, Anaheim, CA
EMP/EMI nuclear effects utilizing radiation hardened components for
missile defense product.
EDUCATION
California State Polytechnic University, Pomona, CA - BSEE Degree
Statistical Process Control - Palomar College
PROFESSIONAL CREDENTIALS
IEEE and ASQC Affiliation
Contact this candidate