Quality Medical Device
Resume:
*************@*****.***
Michelle A. Billitier
Objective To obtain a position in quality management/systems
where there is room for growth and self improvement
Experience 2012-2013 Eldre Corporation Rochester, NY
Quality Engineer
Main point of contact for Aerospace customers
Reviewed PO's and contracts for quality
requirements
Implemented and executed unique aerospace customer
requirements
Prepared FAI reports in accordance with AS9102
requirements
DQR for aerospace customer- able to source inspect
and release product on their behalf
Successfully implemented an improved internal audit
system that was more process driven using turtle
diagrams
Managed approved supplier list
2011-2012 Northern Air Systems Rochester, NY
Quality Manager
Management Quality System
Successfully implemented ISO 9000:2008
ISO Management Representative
Managed internal and external non conforming
product and CAPA using QCBD (Quality Collaboration
by Design) database
Reduced scrap by 35% using 5S methodology when data
showed that 75% of the scrap generated was due to
cluttered and unorganized work space
Generated monthly company performance reports for
upper management
2009-2011 PEKO Precision Products
Rochester, NY
QMS Administrator/Quality Engineer
Maintained all QMS documentation
Administered various training programs. (i.e. new
employee orientation, GMP & GDP, new or updated
procedures)
Successfully implemented AS9100C
Managed internal audit and CAPA systems using home
grown access database. Followed up to ensure
timely completetion.
Scheduled and was the lead company representative
in all 3rd party audits including those conducted
by Medical Device, Aerospace and Defense customers
as well as those conducted by the registration
body.
Quality Engineer for all Aerospace
customer/programs
Prepared FAI reports in accordance with AS9102
requirements
Familiar with ISO 13485 and some of the 21 CFR 820
regulations
Developed and maintained Device Master Records
(DMRs) and Device History Records (DHRs) for
specific Medical device customers
Lead internal auditor for AS 9100C & ISO 13485
1989 - 2009 Magnetic Technologies Corporation
Rochester, NY
Quality Manager / Quality Systems Management
Representative
Started as Co - op in 1989 as an inspector.
Promoted to supervisor in 1995 and manager in 2000.
Responsible for overall operation of Quality
functions.
Responsible for monitoring supplier performance and
development. Perform on site audits when
necessary.
Monitor and report Corporate quality performance
indicators. (Scrap, On-Time Delivery and Customer
Returns). Initiate improvement plans when targets
are not met which included assembling cross
functional teams and having brainstorming sessions.
Improvement plans often included further employee
training and reward and recognition when the goals
were met. Also responsible for monitoring and
reporting these metrics internally through the use
of daily Gembas, QDIP boards and PQR's.
Responsible for initiating and leading root cause
analysis teams using 8D and 5 why methodology when
internal or external failures are identified.
Responsible for training employees in various
quality activities and functions (Root Cause
Analysis, FMEA, QS 9000, ISO 9001 and AS9100
Quality Systems)
Appointed as Management Representative by Corporate
Management and successfully implemented ISO
9001:1994, QS 9000, ISO 9001:2000 and AS9100
quality systems.
Responsible for scheduling and facilitating
quarterly management reviews. Documented,
distributed and maintained records of those
reviews.
Responsible for initiating, documenting and
implementing SOP's and product/operation specific
work instructions. Also responsible for the
documentation and implementation of system level
procedures.
Responsible for the overall document control
functions.
Designated Quality Representative (DQR) for major
aerospace customer which meant I was responsible
for carrying out source inspections and releasing
product on their behalf.
Prepared FAI reports in accordance with AS9102
requirements
Lead and facilitate Kaizen and 5S activities which
eventually led to improved process and material
flow.
Managed Approved Supplier List. Supplier
development including on site audits and monitoring
Quality and OTD delivery metrics. Requested
corrective action when metrics were not met.
Responsible for setting up Quality Systems and
Quality Departments at our Chinese and European
facitilities.
Additional Extensive Quality Systems training in Aerospace,
Training and Automotive and Medical Device. Extensive training
Skills: and thorough knowledge of CAPA, root cause analysis
and Failure Modes Effects and Analysis. Extensive
knowledge of GD&T, SPC, Gage R&R, and Lean
manufacturing. Extensive quality auditing training
and execution. ASQ Certified Quality Auditor.
Proficient in procedure/SOP development in various
formats.
Education: Edison Technical High School Rochester, NY
Majored in Technical Machine Shop
Monroe Community College Rochester,
NY
Quality Assurance Technology
Rochester Institute of Technology Rochester,
NY
Quality Engineering
References: Available upon request
Contact this candidate