Engineer Engineering
Resume:
MICHAEL A. HAMEL
Winston-Salem, NC 27105
abnp0q@r.postjobfree.com
Objective: A job position that uses my quality experience, regulatory compliance knowledge, and technical writing
skills to implement and improve quality systems.
Education: B.S. Industrial Engineering, 1976 - North Carolina State University - Raleigh, NC
Experience: Cook Endoscopy 08/2007 – Present Winston-Salem, NC
Supplier Quality Engineer
• Increased the effectiveness of the supplier quality program by working with suppliers to resolve and
prevent material quality issues.
• Worked with Purchasing, R & D Engineering, Process Engineering, and OEM suppliers to develop
Quality Management Systems to reduce receipt of defective components and medical devices.
• Investigated customer complaints due to defective components received from suppliers.
• Performed supplier audits per the audit calendar (referencing FDA 21 CFR Part 820 QSR; ISO
13485:2003; and ISO 9001 requirements) and developed corresponding audit reports.
• Managed Material Review Board (MRB) activities, issued and monitored Supplier Corrective Action
Request (SCARs), and worked with suppliers to achieve timely and comprehensive corrective actions.
• Developed metrics and analyzed supplier data for presentations to the Quality Review Board (QRB)
and quarterly at Management Review.
• Developed and revised supplier agreements and supplier quality procedures.
• Assisted engineers in developing material specifications.
• Worked with product and process engineers to develop and revise material and product IQC inspection
requirements and test procedures.
• Developed Change Requests for manufacturing specifications, drawings, and procedures.
BioMerieux, Inc. 01/2007 – 06/2007 Durham, NC
Supplier Quality Engineer
• Managed the Supplier Quality System according to the FDA 21 CFR Part 820 QSR, ISO
13485:2003, and corporate procedures.
• Worked with Purchasing and suppliers to resolve product quality issues and to reduce the receipt of
defective material.
• Issued non-conforming reports (NCMRs) and performed investigations on defective materials received
from suppliers.
• Performed supplier audits as the Lead Auditor to qualify new suppliers and audit critical existing
suppliers. This included issuing audit reports with requested corrective actions for the audit findings.
• Managed MRB activities, including conducting MRB meetings, issuing and monitoring SCARs, and
working with suppliers to implement corrective actions. This included closing more than 20 open
SCARs from one critical supplier.
• Worked with Purchasing to monitor the SCAR program, track supplier performance, and present
metrics.
• Provided technical support on supplier process improvement teams with Purchasing, Validation,
Production, and R & D. This included successfully improving the manufacturing and packaging
process of a critical supplier and increasing the production output of a major bottle supplier.
• Worked with Process Engineering and QC Incoming Inspection on developing and revising material
specifications, submitting change requests, and revising inspection requirements.
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Michael A. Hamel
SunTech Medical, Inc. 05/2005 – 01/2007 Morrisville, NC
Quality Engineer
• Maintained and improved the Quality Systems to ensure compliance to FDA 21 CFR Part 820 QSR,
ISO 13485:2003, and ISO 9001 requirements. This included performing internal audits, CAPA
investigations, performing document control functions, investigating customer complaints, maintaining
the calibration program, and developing Management Review metrics.
• Managed audit programs related to internal and external audits (FDA and ISO). This included team
participation in obtaining an ISO 13485:2003 certification in September 2005 and functioning as the
prime contact for FDA and ISO regulatory audits and inspections.
• Provided quality support for Manufacturing, Engineering, Materials, Incoming Inspection, HR, and IT
functions.
• Performed supplier audits on prospective new suppliers and existing suppliers.
• Developed quality plans, procedures, and standards for the documentation system. This included a
quality plan for manufacturing operations in China.
• Monitored company performance against quality objectives and reported these metrics monthly.
Sandhills Communications 12/2003 – 05/2005 Sanford, NC
Sales Manager
• Directed and managed all sales functions for family-owned business that provides telephone services
to residential and commercial customers. Responsibilities include developing sales and marketing
programs, identifying growth opportunities, prospecting and developing new clients, providing
customer support, and executing profitable business decisions.
Wyeth Vaccines 01/1997 – 11/2003 Sanford, NC
Senior Technical Writer 09/2002 – 11/2003
• Reviewed, edited, and proofread technical documentation created by the Engineering Technical
Writers including Engineering, Maintenance, and Calibration Standard Operating Procedures (SOPs),
Preventive Maintenance (PM) procedures, training documents, and safety procedures.
Supervisor, Facilities Compliance 02/2002 – 09/2002
• Managed the Facilities Regulatory Compliance Department (9 people) in providing regulatory
compliance support functions to the Engineering, Facilities, and Calibration Departments. Promoted to
this position from the acting supervisor position of Facilities Regulatory Compliance Engineer.
• Directed and coordinated department personnel on conducting manufacturing investigations (MIRs);
developing and revising technical documentation (SOPs, PMs, Lockout-Tagout Procedures, and
training plans); and conducting training sessions of technical documentation for engineering,
maintenance, and calibration personnel.
Facilities Regulatory Compliance Engineer 08/2000 – 02/2002
• Promoted to this position to start up and manage the Facilities Regulatory Compliance Department.
My responsibilities included hiring 4 people during a period of dynamic business growth, building
expansion, and FDA consent decree requirements.
• Managed regulatory compliance functions that included developing and revising technical
documentation; conducting MIR investigations and implementing corrective action commitments; and
conducting training sessions on the technical documentation.
Engineering Technical Writer 01/1997 – 08/2000
• Created, revised, and edited technical documentation including Engineering, Maintenance, and
Calibration SOPs, PM Procedures, engineering specifications, safety procedures, training documents,
and regulatory compliance documents. I was the first Engineering Technical Writer hired by Wyeth
Vaccines in Sanford, NC.
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Michael A. Hamel
• Developed a standardized PM program that provided consistent PM procedures for utility and
production equipment; conducted compliance audits on technical documentation (SOPs, PMs, forms,
logs, and drawings); started a failure analysis program to identify failure trends and high-maintenance
equipment; and started the Maintenance Department Training Program.
Trion, Inc. 04/1985 – 01/1997 Sanford, NC
Manufacturing Engineer 11/1993 – 01/1997
• Performed manufacturing engineering functions supporting the manufacture of indoor air cleaning
equipment (setting time standards, estimating labor and tooling for contract fabrication quotes, cost
reduction projects, methods and process improvements, and purchasing equipment). I was assigned to
this position from the position of Industrial Engineering Manager after a corporate restructure
eliminated the Industrial Engineering Department.
Industrial Engineering Manager 04/1985 – 11/1993
• Directed the Industrial Engineering functions supporting the manufacture of indoor air cleaning
equipment. I supervised three Industrial Engineers in the administration of a “Measured Daywork”
system of performance time standards using standard data methods (MOST) and time study methods.
This system consisted of 20,000 part routings with operations for sheet metal fabrication, welding,
painting, electro-mechanical assembly, and printed circuit board assembly.
• Developed projects for cost reduction, methods and process improvements, material handling
optimization, plant layout studies, capital equipment appropriations, and packaging designs.
Northern Telecom, Inc. 08/1983 – 04/1985 Research Triangle Park, NC
Manufacturing Engineer
• Performed manufacturing engineering functions supporting the electro-mechanical assembly of the
DMS-10 Digital Telephone Switch Systems. My responsibilities included the introduction and
implementation of new product designs and engineering changes.
L & E Commercial Services 11/1982 – 08/1983 Sanford, NC
Sales Manager
• Managed all of the business operations of my family’s hardware store and commercial janitorial
service during the recuperation of my father from a serious illness.
Max Factor & Company 03/1982 – 11/1982 Oxford, NC
Senior Project Engineer
• Coordinated, shipped, and installed all of the assembly lines and support equipment from the Los
Angeles, California facility for the startup of the Oxford, North Carolina facility. This project was
completed on schedule.
Coty, Division of Pfizer 08/1979 – 03/1982 Sanford, NC
Bulk Compounding Supervisor; Industrial Engineer
• Supervised 13 people and the production processes used in the batch manufacture of creams, lipsticks,
toilet water, perfume, and powder products. I was promoted to this position from the position of
Industrial Engineer, where I performed all standard industrial engineering functions.
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Michael A. Hamel
Eaton Corporation 01/1977 – 08/1979 Sanford, NC
Quality Control Engineer; Manufacturing Engineer
• Performed quality assurance functions for the Chrysler speed control products and AMC emission
control valves. I supervised 5 receiving inspection and line inspection personnel and performed
supplier audits, internal audits, and product reliability testing using statistical process control methods.
I was promoted to this position from the position of Manufacturing Engineer, where I performed
manufacturing and industrial engineering functions for the Chrysler speed control products and AMC
emission control valves.
Skills and
Training:
• Computer skills with MICROSOFT OFFICE and Computerized Maintenance Management Systems
• Completed training on ISO 14971:2007 Application of Risk Management to Medical Devices by
RA/QA International L.L.C. (2008)
• Completed a course on “Managing Priorities and Deadlines” by SKILLPATH SEMINARS (2008)
• Completed training on “Auditing Quality Systems”, “FDA QSR/GMP & Inspections”, and “ISO
13485:2003 Understand & Implement” by Noblitt & Rueland in 2005
• Completed TapRoot® Incident Investigation and Root Cause Analysis Training (2001)
• Completed a course on “Measuring Preventive Maintenance Performance” from the Advanced
Manufacturing Institute (1999)
• Completed a course on “Writing Standard Operating Procedures to Meet cGMP Requirements” from
the Institute for Applied Pharmaceutical Sciences (1997)
• Completed a course on “Mapping Operating Procedures” (1997)
• Completed a course on “The Basics of Writing Policies and Procedures” from the American
Management Association (1995)
• Completed a Technical Writing Course from the American Management Association (1994)
• Completed a course on Juran Quality Improvement (1992)
• Trained on “Trackwise” and “Livelink” document control systems.
Qualifications:
• Prior member of the Society for Technical Communication and the Institute of Industrial Engineers
• Prior technical writing instructor in the Pharmaceutical Science curriculum at Campbell University
(1998)
• Prior evening instructor at Central Carolina Community College teaching industrial management
courses
• Edited the article “The Implementation of a Manufacturing Execution System (MES) within a
Biological Manufacturing Company” written by Frank S. Kohn, PhD and David Williamson for the
May/June 2000 issue of Pharmaceutical Engineering magazine
References:
• Provided upon request.
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