<html> <body> Ed Siurek </body> </html>

Ed Siurek

Sr. Director, Quality Consulting

Throughout his 30+-year career, Ed Siurek has led quality and regulatory departments within the pharmaceutical and medical device industries for both US and international products. He has directed quality and productivity improvement on corporatewide projects in these sectors, spanning 6 continents and 55+ countries. His work has included organizational implementation and oversight of quality management systems, with both primary and direct responsibility for Regulatory Authority interactions. As part of Ed’s role, he has successfully worked with FDA to remediate FDA 483s, warning letters, and consent decrees. He has directed new facility startups and product launches both domestically and abroad. He has led programs and projects serving numerous functions, including medical device product development and launch, ISO 9000 and ISO 13485 certification, EU MDR, quality assurance and regulatory affairs management, Lean/Six Sigma implementation, and global project management leadership, among others.

ED at a Glance

Audit Expertise

  • EU MDD/EU MDR
  • MDSAP
  • ISO 13485
  • 21 CFR 820, 806, 803, 211
  • ISO 9001

QMS Process Expertise

  • PREMARKET
    • Design Control
    • Document Control
    • QMS Implementation
    • ISO 14971/Risk Management
    • IEC 62366/Human Factors
    • IEC 62304/Software Validation
  • PRODUCTION
    • ISO 14971/Risk Management
    • 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 (CER)
    • Postmarket Surveillance
    • FDA & NB Remediation

Regulatory Submissions

  • US, Canada, Europe
  • 510(k) Submissions
  • CE Marking – Technical Documentation, Design Dossiers, Risk Management Files, Essential Requirements Checklists

Education

  • BS, Chemistry – Purdue University
  • MA, Information System Management – Keller University

Certifications

  • Oriel STAT A MATRIX Certified 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.

Ed’s Areas of Expertise

Ed has served in a number of functions in the industry, which have given him a well- rounded perspective on handling a wide range of QMS and regulatory issues for Oriel STAT A MATRIX’s customers.

  • Auditing – Baseline, compliance, and supplier audits to EU MDD/MDR, MDSAP, ISO 13485, ISO 14971, ISO 9001, FDA QSR, and more
  • FDA Remediation – Form 483s, warning letters, consent decrees, recalls
  • Supplier Management – Conducting and managing audits for a wide variety of suppliers across the globe

Highlighted Experience

Some of Ed’s career highlights include the following:

  • Coordinated and implemented a training solution to address a consent decree from US FDA, including training all employees and industrial counterparts to handle pharmaceuticals and medical devices properly. At the completion of the project, the decree was lifted and the company faced no regulatory actions by FDA.
  • Led the development, rollout, training, and oversight of an international corporate complaint and CAPA system. This system was initially used for the medical portion of a larger multinational organization but was later adopted for use throughout the entire organization.
  • Established a program providing vendors with education, procedures, and compliance audits:

    - Continuously provided training to all levels of divisional employees.

    - Managed vendor and product compliance for multiple European- and Asian- based vendors against both internal and external (regulatory) requirements.

  • Successfully managed and mitigated an FDA warning letter for a newly acquired division within 6 months. Worked directly with an FDA regional enforcement officer to establish and report all plans, goals, and metrics on a regular basis.

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