Quality Assurance Engineer
Resume:
Sam Fakhoury
***** *. *** **** # *** Canyon Country, Ca 91387 E-mail:
*******@***.*** Tel: 661-***-****
Summary
A Quality Manager & Quality Engineer with over 10 years of extensive
experience in Quality Assurance, Regulatory Affairs, Compliance,
Manufacturing, Industrial and Operations Execution within FDA / ISO
Regulated Medical Device and Pharmaceutical Industries. Proven
international compliance background from Class I to Class III medical
devices. Successful professional in Business Development, Mergers &
Acquisitions, Service, Sales & Marketing. Proven ability to execute
strategy leveraging a full complement of business acumen, versatility, and
knowledge of bringing products from inception to distribution. An inspiring
visionary skilled at attracting great talent and building teams.
Specialties:
. Medical Devices, Healthcare IT, GMP and Compliance.
. Harmonization and Integration of Quality Management Systems.
. Electronic Engineering Certified.
. Lean Six Sigma, Risk Management, Systems development life-cycle and
Capability Maturity Model Integration
. Practical discrete and process manufacturing experience and embedded and
stand-alone software applications.
. Development, production, and deployment of enterprise applications-- high
transactional, commercial applications to customized, integrated solutions.
Education
. Chapman University
Masters in Business Administration with a Concentration in Quality
Assurance (Expected 3/2014)
. University of Phoenix
Bachelors of Science in Business Management with a Concentration in
Quality Assurance (2011)
. Southern California Institute of Technology
Associates of Science in Electronic Engineering (2002)
Certificates
Certified Electronic Engineer by the Southern California Institute of
Technology (2002)
Experience
. Assistant Manager of Quality Assurance / Currently acting as the
Global Manager of Quality Assurance (8/2012 - Present)
Bioness, Valencia, CA
o Achieved ISO 13485 certification for the company.
o Created and implemented a Global Quality System.
o Designed, implemented and maintain product Quality assurance
systems and
activities in numerous areas such as documentation, inspection,
process validation, product
qualification, calibration, reliability and regulatory affairs.
o Develop corporate and organizational policies and procedures.
o Regularly interact internally and externally with, suppliers,
and outside regulatory bodies requiring significant tact and
diplomacy.
o Facilitate and manage quality strategies development, Quality
planning activities, Risk
management (Use, Design and process FMEAs, Hazard analysis)
Verification/Validation strategy development and execution (e.g.
Test method validation, Software validation, process validation,
Design verification and validations).
o Participate in the development, implementation and maintenance
of quality related
infrastructure systems.
o Provide leadership to project team members in the use of data
analysis tools (e.g.
descriptive/interferential statistics, Minitab, DOE, Six sigma
tools etc.) .
o Represent the company during agency, notified body or other 3rd
party audits and in
vendor related issues.
o Work extensively with the external partnerships and establish
effective systems to
manage failure analysis, QA system requirements, effective
change control, QA reporting and manufacturing defect analysis.
o Data and reporting based on these QA systems will be a part of
QA key reporting
metrics.
o CAPA and SCAR Manager
o Failure analysis Manager
o NCR reduction management
o Managed all Suppliers domestic and international.
o Manage all Validations.
o Manage all Quality systems.
o Manage Quality Control.
. Senior Compliance Quality Engineer (4/2012 - 8/2012) (Consultant
through Abacus)
Advanced Sterilization Products (Subsidiary of Johnson and Johnson),
Irvine, CA
o Lead all Field Action activities.
o Handled all Field Action Updates and correspondence with the FDA
in a timely manner.
o Worked with the Technical team in regards to implementation of
technical bulletins.
o Organized, participated and provided input in QRB Filed action
decisions.
o Directed Customers and affiliates on compliance requirements.
o Responsible for coordinating cross functional teams and QS
metrics reporting to ensure that compliance is met with defined
procedures.
o Provided compliance and quality system support of special
projects directed by the Compliance & Quality Systems Director.
o Lead weekly meeting with international affiliates in regards to
all field action and Technical Bulleting activities.
o Managed all field action activities on a Domestic and Global
Scale.
. President (11/2008 - 3/2012)
Fakho Healthcare, Riverside, CA
o Grew the company to $475,000.00 a year in sales by 11/2009
(Within one year of starting the company).
o By the last year of ownership under my leadership, the company
grossed $1,109,044.00. (3 years and 5 month after starting the
company).
o Was recognized as an aggressive competitor in medical supplies
industry from a quality and pricing standpoint.
Had an average annual complaint rate of .10%.
Averaged sales of 128% growth annually.
Managed Finance, Sales, Marketing, Planning, Inventory, Quality and
customer service.
Started the company on my own and ended up hiring 5 full time
employees (1 Quality Inspector, 2 Sales Representatives, 2 Customer
service representatives) by the time I sold the company.
. Senior Quality Engineer (5/2010 - 3/2012)
Sea Spine (Subsidiary of Integra Life Sciences), Vista, CA
8 Provided a strong quality direction in new product development and design
change efforts to ensure that products meet performance/quality
specifications and are highly manufacturable.
9 Worked with Metals and plastics. (Peek, Stainless Steel, Nitinol,
Titanium, etc)
10 Developed critical-to-quality specifications, test plans, protocols,
procedures, tools, meaningful metrics and controls for all aspects of
manufacturing, packaging, cleaning, sterilization, inspection and
shipping.
11 Developed plans and oversaw the qualification of new suppliers and raw
materials domestically and internationally.
12 Worked quickly and permanently to resolve supplier quality issues.
13 Took a leadership role on customer complaints to identify, coordinate
and effectively resolve problems in a timely manner and maintain GMP
and ISO 13485 compliance.
14 Responsible for complaint analysis, trending and reporting of complaint
data using standard statistical techniques and presentation software.
15 Trained others in support of Seaspine's quality culture.
16 Specified and design inspection, test methods, fixtures, and set-ups for
the Quality Control Department and vendors.
17 Developed and implemented policies, procedures and work instructions for
the Quality Control Department.
o Represented the Quality department in MRB quarterly meetings.
. Senior Manufacturing Engineer (11/2009 - 4/2010) (Consultant through
Apex Systems)
Baxter, Irvine, CA
o Managed 5 Direct reports. (3 Technicians and 1 Engineer)
o Led Project Management efforts.
19 Worked with Plastics, adhesives and curing systems.
o Worked in a Rapid prototyping facility with design team.
20 Evaluated, analyzed, and made recommendations on products, designs, and
cost improvements to improve the competitive position of the company.
o Evaluated Gamma Ray sterilization and E-beam capabilities and
effects to product for sterilization validation.
o Prepared, executed, and created reports on engineering studies
as well as Installation Qualification, Operation Qualification,
and Process Qualifications.
o Prepared and revised manufacturing operating procedures and
specifications to accommodate new product line implementation
and manufacturing.
o Provided manufacturing engineering input into the program core
team to ensure products are designed for consistent quality and
manufacturability, including the integration of 6 sigma tools
and lean manufacturing principals.
o Created conceptual designs for tooling required for production.
o Wrote machine requirements specifications for capital equipment,
worked with quality, manufacturing and engineering teams to
reach agreement on the requirements of equipment.
o Worked with independent machine builders through conceptual
design, quoting, design-review, machine build and acceptance to
ensure plant requirements are met.
o Organized teams from quality, manufacturing, engineering and
maintenance and planed the installation, validation and
implementation of the newly produced equipment.
o Planed and developed test programs for prototypes.
o Analyzed test data and reports to determine if designs meet
functional and performance specifications.
o Provided technical/manufacturing engineering support in all
phases of product development through design transfer.
o Analyzed, evaluated, and recommended cost improvement ideas
through new product, vendor, and design changes.
o Managed Supervisors and technicians.
o Managed project budget.
. Senior Quality Engineer (3/2009 - 10/2009) (Consultant through Kimco
Staffing)
Core Valve (Subsidiary of Medtronic), Irvine, CA
o Managed 2 Direct Reports (1 Engineer and 1 Technician)
o Led Project Management efforts.
o Managed the technology transfer of machinery, product and
manufacturing with proper documentation and validations in
place.
o Mentor and Manager of Quality Engineering staff responsible for
ensuring principals of design control are properly completed
o Worked closely with marketing.
o Performed risk analysis.
o Improved manufacturability and yields.
o Performed Gage R&R studies.
o Reviewed DHR and released product lots for distribution.
o Reviewed and approved document/drawing changes.
o Wrote non-conformance reports and CAPA reports; determined root-
causes and specified corrective and preventative actions.
o Wrote and revised Quality SOPs.
o Evaluated returned product and designed and executed studies to
determine the root-cause of non-conformities.
22 Wrote Quality plans.
23 Wrote and executed IQ/OQ/PQ protocols, design verification protocols and
Inspection/test method validation protocols.
24 Developed test methods.
o Maintained Design History Files
25 Designed test fixtures
26 Arranged for the fabrication of test fixtures.
27 Wrote inspection procedures and specified inspection methods.
28 Supervise inspectors and technicians.
29 Managed Engineers and technicians.
. Senior Manufacturing / Industrial Engineer (2/2008 - 11/2008)
(Consultant)
Discus Dental (Subsidiary of Philips), Ontario, CA
o Managed 10 Direct Reports (Engineers and Technicians.)
o Led Project Management efforts.
31 Worked with Metals and Plastics. (Peek, Stainless Steel, Nitinol,
Titanium, etc.)
o Worked in a Rapid prototyping facility with design team.
o Managed the technology transfer of machinery, product and
manufacturing with proper documentation and validations in
place.
o Daily interaction with R&D, Marketing, Regulatory Affairs, and
Operations to ensure designed and manufactured devices comply
with regulatory, quality assurance, and product development
guidelines.
o Mentored and Managed the Quality Engineering staff responsible
for ensuring principals of design controls were met and properly
completed.
o Provide support as design chair and/or independent reviewer for
the majority of the critical launch products.
o Oversight of the post launch surveillance program for all
critical launched products.
o Worked closely with marketing.
o Performed risk analysis.
o Responsible for participating in design and development projects
and assuring the design process meets all requirements
o Responsible for reviewing design drawings for tolerance, inspect-
ability and quality of design issues
o Worked with suppliers to improve quality and assist, where
necessary, in supplier process validations
o Strong skills in test plan development and root cause failure
analysis.
o Developed and converted Lean Manufacturing production lines.
o Worked with manufacturing engineering and industrial engineering
to perform design for manufacturability reviews on new product
releases or product changes.
o Worked with planning, manufacturing, quality and suppliers to
review product specifications to develop tooling/fixture
requirements, planned necessary equipment purchases and
developed efficient manufacturing methods & work instructions to
produce parts to estimated cost and quality objectives.
o Was responsible to head up lean manufacturing projects which
included development of value stream maps, process capabilities,
takt time development and other elements to lead Kaizen project
teams to reduce non value added tasks and improve company order
to cash cycle times.
o Developed, evaluated and improved manufacturing methods,
utilizing knowledge of lean manufacturing methods, materials and
parts, fabrications processes, tooling and production equipment
capabilities, assembly methods and cycle times, and quality
control standards.
o Worked with Mfg Engineering to assist on Design for
Manufacturing Reviews on new products to ensure smooth
transition of products from design into manufacturing and
improved time to market. This included writing of manufacturing
work instructions and floor personnel training.
o Lead Lean Manufacturing Projects.
o Developed Value stream maps, process mapping, flow diagrams and
data collection methods on projects to identify Kaizen projects
to eliminate non value added operations and waste in the
factory.
o Ensured supplier/sub contractor readiness for new products.
o Worked with Quality Engineering and Manufacturing Engineering on
IQ, OQ and PQ validations.
o Drove reliability improvement activities in manufacturing and
with design.
o Using Lean Methodology-Developed and maintained effective
manufacturing processes and work instructions.
o Facilitated and improved communications between engineering,
suppliers and manufacturing on all new product changes and new
product releases.
o Perform DFM reviews on all new product changes and releases to
improve time to market and product reliability.
o Developed and executed IQ, OQ, PQ validations.
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