Senior Quality Engineer Resume RTP, NC - Hire IT People

SUMMARY

Biomedical Engineer with experience in product design and development, biomechanics research, manufacturing operations and process development, quality assurance and DHF remediation.
Seeking employment with a growing Biomedical Engineering firm.
US citizen currently living and working in Virginia.

TECHNICAL SKILLS

Programming skills: C++, DOS, UNIX, FTP Programming

Modeling packages: AutoCAD, Solid works, ADINA, ANSYS ICEM, Autodesk Inventor

Mathematical packages: MATLAB, Python

Experimental skills: Basic circuitry & microprocessors, 3D printing (Rapid Prototyping), 3D scanning, GD&T for Quality Control of Medical Devices component

Compentencies: Verification & Validation, Process Validation, Risk Management, Quality Control, Root Cause Analysis

PROFESSIONAL EXPERIENCE

Senior Quality Engineer

Confidential, RTP, NC

Responsibilities:

Technical report authorship; review and formatting for intraocular device characterization and verification testing using NO2 gas sterilization.
Aided in characterization of the NO2 parameters for the intraocular device sterilization.
Data analysis included statistical analysis using Minitab software to quantify and analyze verification validation testing data.
IPCD/ePCD SOP authorship for BI sterility and Bioburden validation testing
Facilitated manufacturing and complaint investigation reviews and approvals of 3000 backlogged complaints.
Expert DHF and Life cycle management support
Gap analysis and technical review of a Microneedle Transdermal delivery system DHF.

Quality Assurance Engineer

Confidential

Responsibilities:

Worked on a cross - functional project team through all phases of the design control process from planning and concept to product launch and initial production ramp-up including post market design change implementation
Partnered with operations to understand manufacturing process capabilities and equipment capacity to ensure proper design transfer for new products
Analyzed, documented, and communicated results to the broader team
Reviewed and approved design inputs, outputs, verification and validation documentation
Authored acceptance test procedures, quality plan and validation protocols and reports.
Generated qualification plans, protocols, testing methods, and reports for new or updated manufacturing validation processes and equipment (IQ/OQ/PQ)
Trained production level employees on key manufacturing and testing processes
Examined options and implementing action plans for materials / components that non-conforming
Provided reliability input in the evaluation of discrepant material and in the qualification of new materials
Created inspection criteria forms with proper inspection methods and sampling rates to ensure device reliability standards are met
Lead and participated in teams to resolve production and customer issues through root cause and implementing remediation
Lead and participated in complaint investigations through failure analysis of returned products
Provided support to outside sales force and customers to resolve product technical questions and instrument performance concerns

Quality Assurance Engineer Consultant

Confidential

Responsibilities:

Completed the Design History File Remediation process and participated as part of the Tech Files team
Assessed system and functional requirement specifications for a number of Confidential ’s MIC products, compiled a list of specifications that needed retesting, and co-wrote testing protocols
Gained skills in working across the value chain of a MIC product through direct collaboration with teams from the main site in Laurel, Maryland to the design ownership transfer site in Bangalore, India to the new manufacturing site in Madison, Wisconsin

Junior R&D Engineer

Confidential

Responsibilities:

Retrospectively built and remediated company design history files
Gained a thorough understanding of and applied design control SOPs and FDA guidance and regulations 21 CFR 820.30, 21 CFR Part 4, ISO 13485, ISO 14971 and IEC 62366
Collaborated with project teams, vendors and suppliers to assess and manage risk and create FMEAs
Identified gaps in design history files in accordance with company standards
Drafted combination product design control documentation: DFMEA, Risk Management Plans, Fault Tree Analyses, Rationale Documents and project plans

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Senior Quality Engineer Resume

Rtp, NC

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