Summary
Overview
Work History
Education
Skills
Certification
References
Timeline
Generic

CORINA NEACSU-GUTH

Surprise

Summary

Quality control professional with 20+ years in Quality Assurance within the medical device sector. Expertise in CFRs, GMPs, ISO 13485:2016, and ISO 9001, with a strong focus on CAPA, SCARs, and risk management. Successfully led ISO 13485:2003 implementation in two organizations, resulting in improved operational efficiency and enhanced staff training. Skilled in defining quality requirements for suppliers and monitoring compliance with established procedures.

Overview

23
23
years of professional experience
1
1
Certification

Work History

QUALITY ASSURANCE MANAGER

ZIEHM ORTHOSCAN
SCOTTSDALE
07.2023 - 08.2024
  • Proven quality assurance manager with over 20 years of professional experience in recuperating customer satisfaction, preventing critical quality issues and optimizing team performance. Provided coaching, mentoring and leadership to the Quality staff.
  • Formulated, wrote, and maintained procedures for the quality control of Ziehm Orthoscan products; maintained the systems and documentation required to sustain the 21 CFR Part 820, total quality system, and compliance to applicable International Standards, such as ISO 13485:2016, as required.
  • Responsible for ensuring that the site maintained operational and quality systems in a state of compliance to domestic and international standards.
  • Documented and reported on the effectiveness of company processes to management, including batch record review, batch release, deviation investigations.
  • Determined supplier qualification risks based upon criticality of component and supplier process capability.
  • Efficient, dynamic, agile, and hands-on manager identified key process indicators for all major process areas, eventually leading to a decrease in potentially detrimental quality oversights.
  • Helped maintain a hybrid compliant quality management system between two domestic sites.
  • Established, monitored, and reported on appropriate Key performance indicators which underpin the performance of Ziehm Orthoscan relative to Quality for Operations, Quality System, and Product Development.
  • Created and maintained quality documentation related to products, including supplier qualification documentation, corrective and preventative actions (CAPA), and internal audits.

QUALITY MANAGER

ZIMMER BIOMET
SCOTTSDALE
02.2018 - 05.2023
  • Lead the maintenance and enhancement of the overall Quality Management System (QMS) to achieve on-time quality deliverables, high customer value, and profitable results. Assured product conformance to established requirements and standards through appropriate inspection and test activities.
  • Responsible for the organization, documentation and maintenance of the quality system to be compliant with, as appropriate, the following standards: ISO 13485, MDSAP and 21 CFR Part 820, EU MDR and other applicable standards.
  • Served as the site's Management Representative (deputy for the site) and lead the organization's Management Review process.
  • Monitored and escalated supplier performance issues to key stakeholders, using Microsoft Excel for raw data collection and analysis, increasing quality control metrics by 20% between 2022-2023.
  • Ensured suppliers were managed on the Approved Supplier List (ASL) and all required documentation was maintained.
  • Collaborated with 3 cross-functional teams to provide support with internal CAPAs, nonconformances, SCARs, Issue Evaluation and supplier corrective actions (SCARs) investigations.
  • Conducted over 10 internal and supplier audits on average per quarter, following regulations and standards requirements, capturing internal and supplier quality performance inefficiencies to ensure compliance with the requirements.
  • Hosted and participated as SME in Corporate and Notified Body / MDSAP audits.
  • Conducted quarterly Management Review Meetings as a deputy Management Representative.
  • Collaborated with 4 cross-functional teams and different external stakeholders, using Microsoft Teams and goal-settings strategies, improving quality goals by 95% within Q1, 2023.

SR. SPECIALIST, QUALITY SYSTEM

WEST PHARMACEUTICALS, INC.
SCOTTSDALE
03.2017 - 02.2018
  • Provided expertise in managing complex initiatives, analyzed organizational quality systems and processes and made recommendations for improvements. Managed and executed GMP compliance programs and provided support to key quality systems.
  • Recommended, evaluated, and implemented process changes that were designed to continually improve the quality management system (NCR, CAPA, Complaint, Audit, etc.).
  • Performed activities related to the documentation, control, disposition and root cause analysis of the non-conforming material.
  • Ensured compliance with appropriate domestic regulatory and international standards and requirements.
  • Worked closely with Manufacturing and Quality Control to resolve open issues resulting from aged record reviews, internal audits of the facility, Issue Reviews and NCRs.
  • Maintained and reported Quality Metrics to demonstrate areas of improvement and state of compliance.
  • Oversaw the internal and external audit program to ensure compliance to internal /external requirements, including customer requirements; coordinated customer audits.
  • Completed and managed Quality Assurance related documentation required for customer relationship such as supplier questionnaires.
  • Reviewed and updated documents and submitted these to MasterControl for approval and release.
  • Collaborated with 4 cross-functional teams to identify opportunities to streamline quality processes and workflows.

QUALITY ENGINEER

REGENESIS BIOMEDICAL
SCOTTSDALE
08.2012 - 01.2017
  • Highly motivated team member with excellent organizational, communication, and technical problem-solving skills. Proven track record of consistently handling multiple tasks demands in a timely manner.
  • Participation in activities assuring internal compliance as well as with the FDA & ISO 13485.
  • Successfully managed and implemented the eMDR and UDI requirements.
  • Developed and managed the complaint process to ensure customer responsiveness and product and process improvements; acted as SME for complaint processes during internal/external audits.
  • Led the organization's continuous improvement process, including data analysis and improvement projects to improve key metrics as measured by the product/service quality dashboard.
  • Oversaw the Corrective and Preventive Action (CAPA) program, implemented measures to monitor the effectiveness of the CAPA system, verified effectiveness.
  • Planned and conducted audits of the QMS to evaluate compliance with the requirements.
  • Administered and conducted internal and supplier audits, initiated supplier corrective action reports (SCARs).
  • Conducted and maintained meticulous record of all training related to GMPs, SOPs, corrective actions, etc.

QUALITY MANAGER

TJM ELECTRONICS
TEMPE
05.2011 - 07.2012
  • Mentored the Executive Management Team and Medical Device Team toward the requirements of ISO 13485:2003 and 21 CFR 820. Defined and set up a QMS that complied with the FDA QSR and ISO 13485:2003 standards. As a Management Representative, led the organization's Quality staff to ensure compliance to the overall Quality Management System and drive continuous improvement. Led the company to successful ISO 13485:2003 certification.
  • Developed and implemented and revised standard operating procedures, work instructions, and records.
  • Trending of Quality Systems metrics including CAPA, NCMR, deviations, audits, and CCB.
  • Worked in a controlled environment directly with manufacturing and engineering on testing and release of materials, components and completed products.
  • Established comprehensive Quality System training program and conducted training to all employees.

QUALITY ENGEER / QUALITY ASSURANCE MANAGER

AMERICAN MEDICAL SYSTEMS (AMS)
PHOENIX
05.2006 - 10.2010
  • Ensured consistent and continuous production as well as maintained operation's adherence to quality system and documentation standards as stated in the FDA, cGMP and ISO 13485:2003 regulatory guidelines. Facilitated the deployment of complaints systems; assessed field returns and conducted failure mode analysis in order to determine any failure trend; as well as reviewed of medical device complaints, US Medical Device Reports (MDR) and international medical device vigilance reporting. Led and supervised quality assurance team and oversaw the accomplishment of day-to-day quality assurance duties and activities including the resolution of quality concerns in all phases of design control and manufacturing.
  • Planned, scheduled and completed projects in accordance with company objectives.
  • Reported project status to management and executed other tasks related to report outcome.
  • Designed and implemented quality training programs for employee development.
  • Developed and managed the complaint process; acted as an SME for complaint processes during internal/external audits, prepared and reported complaints data metric/trends to upper management.
  • Oversaw corrective action team meetings to coordinate with CAPA system to ascertain that all items were closed effectively.
  • Developed and organized quality training program to mentor personnel on good manufacturing practices, FDA regulations, quality system regulations, complaint handling and ISO 13485:2003, among others, as well as scheduled training sessions and documented employee training records.
  • Performed internal and intra-company quality system audits to ensure conformance to AMS' quality system and regulatory requirements.
  • Efficiently revised procedures and developed forms and instructions for recording, evaluation, and quality data reporting.

QUALITY ENGINEER

THE TECH GROUP (WEST PHARMACEUTICALS)
TEMPE
09.2001 - 05.2006
  • Documented quality control and inspection procedures for receipt of materials, in-process injection molded components and final acceptance activities to establish quality assurance requirements as well as implemented and facilitated the latest revision of the ISO 13485 quality system regulation.
  • Worked in a controlled environment, performing inspections, tests, and sampling procedures of incoming material and in-process injection molded components used in the manufacture of medical devices to ensure efficient release of finished goods through detailed review of Device History Records.
  • Conducted PerkinElmer Spectrum One Fourier Transform Infrared (FTIR) Spectrophotometer assay.
  • Assisted in the development of new automated assembly lines and test procedures for IQ, OQ, and PQ.
  • Facilitated gage R&R and first article inspection; supported capability analysis and Design of Experiments.

Education

MBA - GLOBAL MANAGEMENT

UNIVERSITY OF PHOENIX
AZ

BA - LINGUSITICS

BABES-BOLYAI UNIVERSITY
ROMANIA

Skills

  • CAPA and NCR management
  • Root cause analysis
  • Documentation control
  • Supplier quality assurance
  • Employee training
  • Medical device complaint resolution
  • Complaint handling and investigation
  • Internal and supplier audits
  • Contract manufacturer oversight
  • Microsoft Office Suite proficiency
  • ETQ Reliance expertise
  • Minitab statistical analysis knowledge
  • JD Edwards and SAP knowledge

Certification

  • ISO13485:2016 - Lead Auditor certificate from BSI
  • ISO 13485:2003 (Medical Device - Quality Management Systems)
  • ISO14971:2007 (Risk Management for Medical Devices)
  • Process Failure Mode Effects Analysis (PFMEA) with Control and Action Plans
  • Root Cause Analysis (RCA) and Corrective Action-Preventive Action (CAPA)
  • Internal Auditing (ISO 9000)

References

Available upon request.

Timeline

QUALITY ASSURANCE MANAGER

ZIEHM ORTHOSCAN
07.2023 - 08.2024

QUALITY MANAGER

ZIMMER BIOMET
02.2018 - 05.2023

SR. SPECIALIST, QUALITY SYSTEM

WEST PHARMACEUTICALS, INC.
03.2017 - 02.2018

QUALITY ENGINEER

REGENESIS BIOMEDICAL
08.2012 - 01.2017

QUALITY MANAGER

TJM ELECTRONICS
05.2011 - 07.2012

QUALITY ENGEER / QUALITY ASSURANCE MANAGER

AMERICAN MEDICAL SYSTEMS (AMS)
05.2006 - 10.2010

QUALITY ENGINEER

THE TECH GROUP (WEST PHARMACEUTICALS)
09.2001 - 05.2006

MBA - GLOBAL MANAGEMENT

UNIVERSITY OF PHOENIX

BA - LINGUSITICS

BABES-BOLYAI UNIVERSITY

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