Sr. Quality Engineer Resume Brooklyn Park, MN - Hire IT People

OBJECTIVE:

To secure a Computer/Automation System Validation, Project Management, Quality/Mechanical Engineering or Remediation position in a team oriented environment utilizing FDA 21 CFR Parts 820, 211, 210, and 11 and ISO 13485, 9001 standards.

SUMMARY

Managed and conducted computer, equipment, laboratory, test method & process validations at major international pharmaceutical companies, biotechnical, medical device manufacturers, blood processing facilities; and additionally for vendors providing software and hardware to these industries.
Formulation and implementation of validation master plans promoting regulatory compliance in automated facilities, computer integrated processes and computerized laboratories.
Development and execution of validation protocols such as qualifications (IQ/OQ/PQ/DQ), standard operating procedures (SOPs) and cGMP compliance (GMP and Part 11) training programs.
Develop and conduct cGMP audits and compliance programs for clients and their vendors involved in areas such as design and construction, process equipment design and installation, and computer systems design and implementation.
Project management and supervisory role administered throughout many validation project assignments in pharmaceutical and medical device companies.
The guidelines implemented throughout these validation projects have been based upon FDA cGMP and cGLP regulations and ISO standards.
Automated material movement, storage and management systems for solid dosage manufacturing facilities.
Computer integrated process equipment such as sterilizers, lyophilizers, tablet compression equipment, packaging equipment, and other manufacturing systems.
Integrated control systems used in plant automation, environmental and equipment monitoring, building automation and HVAC systems.
LIMS and laboratory data acquisition systems such as in vitro diagnostic equipment, GC/LC/MS systems, and associated clinical data management systems.
Computer systems involving material requirements and planning, order entry management, and manufacturing systems controlling product traceability and dispositioning.
Remediation projects starting at the Gap Analysis phase for CAPAs, consent decrees and warning letters.
Software test planning, test case development, execution of scripts, and reporting the results.

TECHNICAL SKILLS

MS - DOS
MS Windows 3.x
95
98
NT
2000
XP
Vista
& 8. Networking including Novell
NT & Lantastic
C++
VB6 dBase
FoxPro
Clipper
Access
PLC ladder logic
OpenVMS & Wonderware.

PROFESSIONAL EXPERIENCE

Sr. Quality Engineer

Confidential, Brooklyn Park, MN

Responsibilities:

Quality engineering lead responsibilities involving a medical device manufacturing plant transfer to a new facility and subsequent revalidation activities.
Review and approval of all transfer documents required per internal quality system.
Rewrite manufacturing processes and qualification documents as required. Monitor deliverables pertinent to preventive maintenance and calibration pre and post transfer.
Developed an equipment specification and managed the project introducing an automated vision inspection system into manufacturing as part of a CAPA.
Developed Gage R&R study to determine mathematical parameters used by vision inspection system.
Qualified label view workstations using zebra label printers.
Programmed and qualified new bar code readers used in production within eTIME.
Involved as validation engineer for a decentralized packaging project involving Belco sealers for 14 product types.

Quality/Validation Engineer

Confidential

Responsibilities:

Auditing of development facility to gain information needed to develop a test method transfer plan for use in a production facility.
Transfer of test methods and protocols to the production facility rewritten into facility specific format.
This was a combination product following cGMPs and ISO 13485.

Software Quality Engineer

Confidential

Responsibilities:

Software Quality Assurance and Regulatory Compliance activities in an ISO 13485 facility ensuring that IS followed the quality management system for an upgrade on a MES (Manufacturing Execution System) project.
Precipitated transition to be followed by changes to the corporate quality systems QMS. Reviewed User Acceptance Protocols prior to execution.
The MES system utilized many IBM Rational products for SW activities. SAP was implemented, but was customized internally.
Results were captured, compared, and reported via EDMs (Electronic Data Mgmt systems).

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Sr. Quality Engineer Resume

Brooklyn Park, MN

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