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Quality Engineer Medical Device

Location:
Tulsa, OK
Posted:
September 21, 2018

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Resume:

MELRITA GILLIAM

Tulsa, Oklahoma

Mobile: 918-***-****/918-***-****

ac64pn@r.postjobfree.com

Experienced Study Director/Analytical Chemist/Quality Engineer

Quality focused, detail oriented diversified Analytical Chemist and Supervisor with 2 year experience in FDA regulated environment. Proven to be skilled at learning new concepts quickly able to work under pressure, communicate ideas clearly and effectively, both verbally and in writing. A dynamic supervisor with excellent multi- tasking skills, experience writing SOPs, modifying SOPs and LOPs, also experienced with MDR, MEDDEV and Supplemental filings as well as CAPA remediations. Experienced in assuring compliance with site Quality Systems procedures and adhering to all parameters of FDA CFR 21 Part 803 FMEA and ISO-9001 and ISO 13485. Experienced working with various regulatory agencies such as OSHA, EPA, FDA, NIOSH, ELPAT, DOD, and DEQ and possess excellent customer service skills. Experienced in preparing Adverse Event Reports per FDA CFR 21 part 803 for Medical Device Reporting and experienced with 21CFR 806, 21 CFR 820.198 and 820.200 for Risk Management. I am experienced with Process and Instrument Validations for both Medical Device and Analytical processes. I have experience in medical terminology and transcription. The ability to apply Quality System Regulations to SOPs, mGMPs, GMP and OSD batch processing. Ability to make decisions that will maximize both individuals and teams through training and positive work ethics, excellent problem solving/troubleshooting and QC skills as well as computer skills.

WORK EXPERIENCE:

Glidewell Dental-Prismatic, Irvine, CA (Advanced Clinical Consulting)

Sr. RA/QA Complaint Specialist

11/2017-06/2018

•Review identified materials for potential complaint information

•Enter identified complaints into complaint database

•Complete MDR Determination forms as necessary

•Create 3500a forms (i.e. MedWatch, MEDDEV)

•Enter international or domestic complaint information into the complaint database

•Conducts or assists with complaint investigations

•Review Quality data to support investigations

•Document complaint investigation results along with other required information per procedure

•Review existing complaints for appropriate MDR reportability decisions

•Augment existing complaint files with appropriate level of documentation

•Complete other documentation as necessary to ensure the complaint files “stand –on- their- own”.

•Discern the level of investigations required for each issue and if CAPA is required to address non-conformances

•Utilize formal problem solving and root cause analysis tools and appropriate application of tools

•Analyze and organize data from multiple sources by utilizing statistical and data analysis tools to identify trends

•Work with manufacturing, product development and quality engineers during the execution of complaint investigations

•Assist MDR Consultants (Adverse Event Specialist) with MDR’s (technical)

•Prepare and submit MDRs for Domestic and International Complaints

•Complete documentation review forms per remediation protocol(s)

•Initiate complaint files in complaints database

•Document MDR Determinations

•Create 3500a’s (i.e. MedWatch)

*Assist with training of other Complaint Specialists

Zimmer Biomet, Warsaw, IN (Maetrics/Theoris Consulting)

Quality Engineer/MDR-Investigator Specialist

09/2016-4/2017

•Review identified materials for potential complaint information

•Enter identified complaints into complaint database

•Complete MDR Determination forms as necessary

•Create 3500a forms (i.e. MedWatch, MEDDEV)

•Conducts or assists with complaint investigations

•Review Quality data to support investigations

•Document complaint investigation results along with other required information per procedure

•Review existing complaints for appropriate MDR reportability decisions

•Augment existing complaint files with appropriate level of documentation

•Complete other documentation as necessary to ensure the complaint files “stand –on- their- own”.

•Discern the level of investigations required for each issue

•Utilize formal problem solving and root cause analysis tools and appropriate application of tools

•Analyze and organize data from multiple sources by utilizing statistical and data analysis tools to identify trends

•Work with Zimmer Biomet’s manufacturing, product development and quality engineers during the execution of complaint investigations

•Assist MDR Consultants/Clinicians (Adverse Event Specialist) with MDR’s (technical)

•Prepare and submit MDRs for Domestic and International Complaints

•Complete documentation review forms per remediation protocol(s)

•Initiate complaint files in complaints database

•Document MDR Determinations

•Create 3500a’s (i.e. MedWatch)

•Document complaint investigations

•Ability to apply components of CFR21 Part 803/806/820, ISO 135485, FMEA, ISO 14971 & MEDDEV 2.12-1

•Obtain or generate objective evidence to support complaint investigations

•Document complaint investigation summaries to support further investigation/no further

investigation decision

•Apply CAPA’s for FDA compliance of product complaints

Covidien/Medtronics, New Haven, CT (Oxford International Contractor)

NHC-PMV-SME & Closing Consultant Team Lead

09/2015-10/2015

•Issuance of Domestic and International Field and Technical Reports by processing allegations of defective products

•Field incoming phone calls from customers and sales force

•SME on all Ballon Products

•Enter all complaint information into Quality Assurance database

•Communicate complaint information to Quality System Analyst for review and follow-up

•Enter international or domestic complaint information into the complaint database

•Communicate FTR numbers to sales representatives

•Filing of processed complaints

•Determine whether a product malfunction or serious occurred due to product malfunction/deficiency

•Review QA/QC investigation for MDR or Supplemental MDR filings

•Determine whether a product malfunction or serious injury report needs to be filed with the FDA

•Determine whether a 30 day or 5 day MDR report is required

•Generate complaint files/ records for litigation purposes

•Evaluate complaints for determining MDR/Vigilance events and document rationale for not filing MDRs

•Ability to utilize Medwatch for Adverse Events

•Maintain complaint records for MDRs

•Filing of Supplemental MDRs when required

•Closing of complaints

•Generate legal letters for follow up to collect additional information from the reporting authority

•Participate in training sessions for sales forces on products

•Demonstrate good documentation practices for operating procedures and complaint records

•Perform final review for closure of complaint files to ensure accuracy, completeness and attention to detail

•Ability to comprehend and apply Quality System Regulations and FDA regulations

•Demonstrate strong knowledge of company products

•Ability to apply components of CFR21 Part 803/806/820, ISO 135485, FMEA, ISO 14971 & MEDDEV 2.12-1

•Ability to apply SOP’s to daily regulatory process and utilization of WindChill, Agile and Master Control

•Maintain required Certifications by local and federal agencies

•Other duties as requested

DePuy Synthes, West Chester, PA (ALKU Quality LLC Contractor)

Analytical Chemist/Study Director

10/2014-07/2015

•Determine whether a product malfunction or serious occurred due to product malfunction/deficiency

•Review External/Internal Laboratory Results including Wet Chemistry reports

•Review product manufacturing scope including process and product blue prints and packaging

•Write Summary Chemistry Reports and Biocompatibility for medical device implants and Safety Hazards associated with implant based on biological and chemical laboratory results reviews

•Data analysis including gravimetric, spectra and chromatograms from various instruments

•Review toxicological results from laboratories for possible contaminants for HHE assessment

•Review packaging and production process for HHE contaminant assessment

•Product risk assessment based on product manufacturing process and product use scope and procedure

•Apply components of CFR21 Part 803/806/820, ISO 135485, FMEA, ISO 14971 & MEDDEV 2.12-1

•Review product packaging for Quality and product manufacturing

•Maintain product process and listings for manufacturing and packaging

•Provide updates and Quality changes to various departments including manufacturing, QA and product engineering

•Polymer Chemistry analysis and review for Biological Safety Evaluations

•Biological Safety Evaluations, Chemical Characterizations

•Process Validation, QSR Retention, Document Change Controls, Labeling, Product Developments and write deviations that address quality changes for products and required product recall

•Prepare post market final evaluation reports that address necessary deviations for product adjustments for use

•Review and provide Worse Case Scenario Exception Reports for products due to required quality assurance deviations

•Provide technical non-conformance and corrective action reports for FDA regulated industry

•Provide technical product recall based on process and labeling non conformance

•Review data and process to determine if the contamination was due to leachable contaminants from packaging, product development, validation or other contact

•Compliance with all regulatory, quality, and safety requirements as required

•Identify contaminants and unknowns from various test results including GC/MS, various digestion and analysis data including ICP/MS, wet chemistry and the review of toxicology reports

•Sterile and Non-Sterile BSE/CTP Splits

•Tech File Remediation

•WindChill, Agile, DocSphere and Master Control

•Ability to utilize Medwatch for FDA Adverse Event Reporting

CR Bard Covington, GA (Alpha Scientific Contractor)

Field Assurance/Post Market Specialist

10/2013-08/2014

•Complaint Intake

•Mailing out of legal letters for complete product/patient/surgical information as part of the investigation process.

•Determine whether a product malfunction or serious injury report needs to be filed with the FDA

•Evaluate complaints for determining MDR/Vigilance events and document rationale for not filing MDRs

•Ability to utilize Medwatch for Adverse Events

•Maintain complaint records for MDRs

•Filing of Supplemental MDRs when required

•Closing of complaints

•Determine whether a product malfunction or serious occurred due to product malfunction/deficiency

•Review QA/QC investigation for MDR or Supplemental MDR filings

Battelle Memorial Institute Stockton, UT

Laboratory Senior Chemist

08/2011-05/2013

Solae/DuPont Protein Technology, Pryor OK

Lab Analyst I

11/2001-05/2006

Outreach Technologies, Broken Arrow, OK

Inorganic/Uranium Lab Supervisor

08/2000-08/2001

Terra Nitrogen, Verdigris, OK

Sr. Laboratory Analyst I

09/1996-11/2000

Standard Testing and Engineering, OKC, OK

Sr. Chemist/Inorganic Lab Supervisor

08/1994-12/1996

ANALYTICAL INSTRUMENTATION:

TJA ICP,TJA X-Series ICP/MS, Perkin Elmer GFAA, Perkin Elmer Hg Analyzer, LECO, UV/VIS Spectrometer, Gross Alpha Beta Analyzer, KPA Analyzer, pH Meter, Karl Fisher Titraitor, Gasoline Rating Engine, TOC analyzer, TLC, and various other Wet-Chemistry instruments, Agilent HPLC, Agilent GC/MS 5975, HP GC 5890, PE HPLC, Agilent Triple Quad GC/MS-MS/MS, PE/ GC, BOD Analyzer, Flash Point Tester, BOD Analyzer

CERTIFICATIONS:

ICP, ICP/MS 07/2012, GC/MS Certification obtained 08/2012, Hazardous Waste Disposal 09/2011, Sr. Chemist Certification obtained 11/2011 for Dept. of Defense, Security Clearance Level-Top Secret, HazWopper Training, OSHA 40 HR Certification, CPR Certification, Chemical Weapons Handling Certification, 8 HR OSHA Refresher 03/2013, Certified M40 Mask, First Responder Certification, ISO-9000 and 9001, AS 9100, Over 1million safe-man work hours, Blood Borne Pathogen Training 2014, ISO 13485, ISO 14971, HIPPA Training 2014, CAPA Training 2011-2013 & 2017, 21CFR 803.3 Medical Device Training, FMEA, 21CFR 820.90 Non-Conforming Products, 21 CFR 820.198 and 820.200, 21 CFR 820.100 CAPA, PCT Certification, 22Hours Nursing Courses including Medical Terminology, cGMP, GLP, QSR, QMS, (Domestic and International) 510K, (Domestic and International) MDV, (Domestic and International)Vigilance Reporting, (Domestic and International) 510K Certification, MEDDEV Reporting, EU Directive, 21CFR 1271.290 (c) Human Cells, Tissues and Cellular Based Products, System Validations, Instrument Validations, Biocompatibility Certification, Chemical Characterization of Medical Devices for Biocompatibility Certification, Biological Safety Certification, (Domestic and International) MDR Reporting, QSR and International Standards Training, Investigation Process and Root Cause Analysis Certification, Governmental Top-Secret Security Clearance

COMPUTER:

MS word, MS Access, Excel, Outlook, PowerPoint, HP GC Software, TrackWise, LIMS, Master Control, WindChill, OMNIC, DocuSphere, Agile,AS400 Production, TQ Analyst (V6), Compliance Wire, MedWatch and ETQ

EDUCATION:

MBA/ MS Healthcare Management American Intercontinental University

B.S. Degree in Biology/AA Degree Chemistry Langston University

PCT Nursing Certificate Tulsa Community College



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