Vittoria King
Golden
Summary
Quality engineering professional with strong background in ensuring product and process excellence; experienced in global medical device regulations and quality systems compliance. Skilled in root cause analysis, process optimization, risk management, and compliance with industry standards. Proven ability to collaborate effectively with teams, adapt to changing needs, and deliver impactful results. Known for reliability, problem-solving skills, and commitment to quality.
Overview
7
7
years of professional experience
Work History
Quality Engineer
ArcScan, Inc.
12.2022 - Current
- Maintains the QMS in accordance with ISO 13485, 21 CFR 820, EU MDR/MDD, MDSAP, and NMPA
- Manages all CAPA investigations, analyses, and delegations of corrective action activities
- Manages all complaints and reportability determinations.
- Manages the approved supplier list (APL) and SCAR investigations
- Manages Material Review Board (MRB) process
- Regulatory and Quality support for Design and Process V&V
- Manages training records
- Handles external audits during annual reviews, ensuring a seamless audit process with minimal findings or discrepancies noted
- Optimized manufacturing processes and documentation to ensure efficiency, traceability, and quality in accordance with 21 CFR and ISO 13485.
- Developed and established the process for handling CAPAs, nonconforming materials, complaints, and regulatory compliance
- Developed inspection plans based on design specifications, ensuring all critical dimensions and performance criteria were verified throughout the manufacturing process
- Developed the action plan for the EU MDR 2017/745 upgrade assessment.
- Improved customer satisfaction levels with timely resolution of non-conformance issues and effective corrective actions.
- Developed metrics and KPIs to monitor trends, enabling data-driven decision-making for process improvements.
Quality Assurance Specialist II
Biomedical Device Consultants and Laboratories
06.2022 - 12.2022
- Review test reports and protocols for regulatory requirements met under ISO 13485, 17025, 21 CFR and guidelines specified in ASTM international standards and ISO 25539, 10555, and 5840.
- Assisted and led internal audit program.
- Performed GLP audits for studies in progress.
- Managed and maintained the QMS.
- Directed investigations for CAPAs and customer audits.
- ISO/IEC 17025:2017 and ISO 13485:2016
QA Analyst II
Botanacor Laboratories, LLC
07.2021 - 06.2022
- Lead implementation processes for test methods in the microbiology and chemistry laboratories.
- Designed Validation Protocols and Reports for the microbiology and chemistry labs.
- Lead CAPA investigations and implemented associated corrective actions.
- Assisted in CDPHE audits and internal audit program.
- ISO/IEC 17025:2017
QA Technician
Botanacor Laboratories, LLC
07.2021 - 11.2021
- Assisted in CDPHE audits.
- ISO/IEC 17025:2017
Microbiologist
Botanacor Laboratories, LLC
08.2020 - 07.2021
- Performed serological testing for yeast/mold, aerobic bacteria, and coliforms/E. coli.
- Performed RNA Analysis utilizing QIAGEN for Salmonella spp. and Shiga-toxin E. coli.
- Provided laboratory support for external audits.
- Participated in R&D projects.
- ISO/IEC 17025:2017
Lab Analyst and Lead
ProEdge Dental Water Labs
12.2019 - 04.2020
- Lead laboratory development for ISO 17025 accreditation
- Developed and implemented the QMS under FDA regulatory requirements.
- Plated and analyzed water samples.
- Performed FCM analysis on water samples.
- Wrote test methods on FCM analysis and plating methods.
- Designed an experiment for the isolation of dead bacteria for further research on the FCM analysis of microbes.
- Designed research on the analysis of spore strips using the Flow Cytometer
Lab Technician
ProEdge Dental Water Labs
03.2019 - 12.2019
- Bioburden testing and analysis
- Revised SOPs for improved testing and analysis
- Wrote SOPs on the lawn plating method, PPE, biological and chemical control procedures, and preparation of chemical and biological suspensions.
Education
Bachelor of Science - Biology, Minor in Chemistry
Metropolitan State University of Denver
01.2019
Skills
- Control plan development
- Quality processes
- Non-conforming material reports
- Quality improvement plans
- Root-cause analysis
- Failure modes and effects analysis
- Risk management
- Materials review
- Process optimization
- Corrective and Preventive Action
- Engineering support
- Supplier quality management
Accomplishments
- Wrote the General Safety and Performance Requirements (GSPR) in accordance with EU MDR 2017/745 Annex I.
- Lead and collaborated with a team of three (3) in the revision of the pFMEA and risk management file.
- Achieved compliance with internal metrics through process improvements.
Timeline
Quality Engineer
ArcScan, Inc.
12.2022 - Current
Quality Assurance Specialist II
Biomedical Device Consultants and Laboratories
06.2022 - 12.2022
QA Analyst II
Botanacor Laboratories, LLC
07.2021 - 06.2022
QA Technician
Botanacor Laboratories, LLC
07.2021 - 11.2021
Microbiologist
Botanacor Laboratories, LLC
08.2020 - 07.2021
Lab Analyst and Lead
ProEdge Dental Water Labs
12.2019 - 04.2020
Lab Technician
ProEdge Dental Water Labs
03.2019 - 12.2019
Bachelor of Science - Biology, Minor in Chemistry
Metropolitan State University of Denver
Similar Profiles
Krystle SwainKrystle Swain
Mechanical Engineering Intern at Arcscan, IncMechanical Engineering Intern at Arcscan, Inc
Adam BrigantiAdam Briganti
Dock Staff Member at Guilford Yacht ClubDock Staff Member at Guilford Yacht Club
Nicholas CallegariNicholas Callegari
Fixed Computer Technical Issues at FriendsFixed Computer Technical Issues at Friends
Joseph DeLaoJoseph DeLao
Respiratory Therapist Specialist at Children’s Hospital ColoradoRespiratory Therapist Specialist at Children’s Hospital Colorado
Jadon HenryJadon Henry
Hockey Coach at In The Crease GoaltendingHockey Coach at In The Crease Goaltending