<html> <body> Omar Gonzalez </body> </html>

Omar Gonzalez

Director, Quality Auditing and Consulting

Omar Gonzalez has over two decades of medical device and diagnostics RA/QA experience in the US, EU, Canada, Australia, Japan, Brazil, and China, working at companies such as Boston Scientific, Beckman Coulter, and Danaher, as well as serving as an auditor for SGS North America. His Notified Body and industry expertise includes serving as a Lead Auditor in auditing to FDA QSR, ISO 13485, MDSAP, and EU MDD/MDR/IVDD/IVDR, as well as assisting organizations to build quality management systems that are in full compliance with a variety of standards and regulations, including EU MDR (2017/745) and IVDR (2017/746). Omar also has extensive experience in supporting FDA inspections, 483/Warning Letter responses, and FDA remediation.

Omar at a Glance

Audit Expertise

  • 21 CFR 820, 803, 806, 11
  • ISO 13485, 14971, 19011, 10993,
  • 17025, 11135
  • EN ISO 11137
  • IEC 63266, 62304, 60601-1
  • MDSAP
  • EU MDD/MDR/IVDD/IVDR
  • Regulations for Canada/CMDCAS, China, Japan, Australia, Brazil
  • EtO and Gamma
  • INMETRO

QMS Process Expertise

  • PREMARKET
    • Design Control
    • Document Controls
    • ISO 14971/Risk Management
    • IEC 62366/Human Factors
    • IEC 62304/Software Validation
  • PRODUCTION
    • ISO 14971/Risk Management
    • Test Method Validation
    • Metrology/Calibration
    • Process Validation
    • Production & Process Control
    • Supplier Control
    • Document Control
  • POSTMARKET
    • ISO 14971/Risk Management
    • CAPA
    • Complaint Handling and Medical Device Reporting
    • Supplier Control
    • Document Control
    • Clinical Evaluation Reports
    • Postmarket Surveillance
    • FDA 483 Remediation
    • FDA Warning Letter
    • FDA Consent Decree
    • NB Major Observations

Regulatory Submissions

  • US FDA 510(k)s & PMA

Performance Excellence

  • Lean Six Sigma/Value Engineering

Education

  • MS, Mechanical Engineering

Training & Certifications

  • ISO 13485 QMS & Lead Auditor

The Oriel STAT A MATRIX consulting team averages 25+ years of life sciences industry experience and has deep expertise in US, European and global RA/QA requirements.

Omar’s Areas of Expertise

  • Regulatory – Providing country-specific RA/QA support for MDSAP requirements; accessing and reviewing clients’ medical device QMS and technical information to the requirements of ISO 13485, and other regulatory requirements – including EU MDR and IVDR; supporting 510(k) and PMA submissions.
  • Quality Management Systems – Supporting the auditing and maintenance of quality management systems for dozens of sites around the globe; implementing quality control systems and developing related specifications, test protocols, and inspections procedures.
  • Auditing – Managing global corporate audits and implementing new audit management databases; auditing corporate QMS to ensure compliance to ISO 13485, 21 CFR 820, MDSAP, MDD/MDR, IVDD/IVDR, and other regulations; conducting gap assessments to EU MDR and other regulations/standards; leading teams of auditors in performing medical device audits.
  • Training – Training auditors and lead auditors on the regulatory requirements for access into Australia, Brazil, Canada, Japan, US, and EU markets.

Highlighted Experience

  • Managed a supplier management program by developing and implementing strategic initiatives to enhance systematic QMS plans for both new and existing products. These efforts realized a substantial annual savings. Also managed problem suppliers to correct chronic quality issues by ensuring the implementation of irreversible corrective actions in manufacturing and quality systems.
  • Conducted auditing and approval reviews of medical devices and in vitro diagnostic devices according to ISO 13485 plus applicable EC Directives (93/42/EEC, 90/385/EEC, 98/79/EC) and Japanese pharmaceutical affairs law.
  • Executed CAPA and effectiveness checks to ensure the effectiveness of CAPA actions associated with quality investigations (QI) in a timely manner.

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