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Medical Device Quality

Location:
Taunton, Massachusetts, United States
Posted:
November 26, 2018

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Resume:

Emma Lutz

* **** **** **., ***. *

Buzzards Bay MA, 02532

774-***-**** / ac7soy@r.postjobfree.com

Profile:

Academic background in Microbiology and public health. Communicates effectively with others at all levels. Well organized, detail-oriented, highly diplomatic, strong dedication to medical device manufacturing/testing. Facilitate practices and procedures without guidance. Can easily comply with regulations and apply them adequately. Well-rounded experience with both Quality Assurance and Quality Control. Well-versed in ISO 13485, ISO 9001, FDA 21 CFR 820 and other current standards/regulations.

Education:

2013-2017 - University of Massachusetts, Amherst MA Bachelor of Science - Microbiology

Bachelor of Science - Public Health

Experience:

February 2018-Present

Neograft Technologies, Inc., Taunton, MA

Associate Quality Assurance Engineer/Document Control

• Reporting to the VP of QA/CA, executes a variety of tasks related to developing and maintaining the companies Quality System.

• Well versed in ISO 13485, ISO 9001, FDA 21 CFR 820, and other current standards/regulations.

• Responsible for some administrative duties, including creating PO’s and purchasing, as well as receiving and inspection of incoming parts, products and chemicals.

• Development and maintenance of documents related to the quality manual including SOPs, Material Specification sheets, DHR/Routers, Technical Protocols/ Reports and related documents.

• Develop and conduct internal audits of the quality system in regards to applicable standards and regulations for Class III Medical device manufacture.

• Development and maintenance of quality system databases, as well as management of all quality system documents.

• Participates in preparing Data/information for Management review meetings, and prepares and displays Quarterly Metrics.

• Follows standard practices and procedures in analyzing situations or data from which answers can be readily obtained.

• Maintains calibration and maintenance for equipment.

• Experience in DCO editing, CAPAs, NCRs, Quality Metrics, and design review meeting minutes and recording.

• Performs Annual reviews including Job description/employee reviews, Document review and Supplier Risk Assessments, as well as conducting employee trainings. June 19th 2017 – January 15th 2018

Zeptometrix Corporation, Franklin, MA

Quality Control Technician

• Ensured quality and conformity of molecular controls through performance of biological assays during product lifespan while maintaining GMP/GLP compliance and all associated documentation

• Working knowledge of audit preparation for regulatory agencies (CDC, FDA, etc.)

• Assisted management with scheduling for validation testing of IVD products

• Performed qPCR, viral/bacterial extractions, ELISAs, sterility testing; SOP optimization, equipment calibration/maintenance; instrumentation including Roche Lightcycler 480 instrument II, Cepheid GeneExpert, Vitros EciQ, BioFire FilmArray, Quidel Sofia

• Communicated with management to avoid scheduling conflicts; executed interdepartmental logistics coordination; performed training of incoming technicians May 31st 2016 – September 2nd 2016

Barnstable County Department of Health and Environment, Barnstable, MA Microbiology Lab Assistant

• Processed all incoming bacteria samples upon delivery to the laboratory in accordance with SOPs

• Operated autoclaves and calibrated various instruments including pH meter and scale

• Prepared all media as well as performing quality control on media to ensure effectiveness and quality

• Entered data using Laboratory Information Management System (LIMS)

• Worked independently on occasion due to schedule of overseeing microbiologist CERTIFICATIONS:

• ISO 13485:2016 Internal Auditor (TPECS)

• MD-Medical Device Management Systems 1.1

• AU-Management Systems Auditing v2.0



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