Patrick Tam

Patrick Tam Email and Phone Number

Corporate Quality Manager - Multi Site @ Sterling Industries
Markham, ON, CA
Patrick Tam's Location
Markham, Ontario, Canada, Canada
Patrick Tam's Contact Details

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About Patrick Tam

Over 23 years experience in Quality System Management specifically in Pipeline Medical Devices, Wound Care Medical Devices and OTC drugs. As Quality System Manager, my primary focus is on Regulatory Bodies audit including ISO Registrars, Health Canada, FDA, GMP, cGMP, Customers, and UL; manufacturing/production processes Quality Improvement; Lab testing processes; QA/QC functions; OOS, NC & CAPA; Supplier Control, Training and the entire Quality System.

Patrick Tam's Current Company Details
Sterling Industries

Sterling Industries

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Corporate Quality Manager - Multi Site
Markham, ON, CA
Employees:
89
Patrick Tam Work Experience Details
  • Sterling Industries
    Corporate Quality Manager - Multi Site
    Sterling Industries
    Markham, On, Ca
  • Sterling Industries
    Quality Manager Canada - Multi Site
    Sterling Industries Sep 2023 - Present
    Woodbridge, Ontario, Ca
  • Gentell, Inc.
    Manager, Quality Assurance
    Gentell, Inc. Sep 2022 - Aug 2023
    Yardley, Pennsylvania, Us
    Responsible for enforcing an efficient compliant, auditing, and quality system program according to senior management approved Quality Plan and company SOPs (Standard Operating Procedures), and GxP, documentation/training management. Provided expertise on the design, implementation, development, changes of GxP systems, processes and procedures. Manage QA auditors' team to ensure internal audits and external audits are performed and to ensure CAPAs are closed out. Manage and evaluate customer complaints to ensure regulations are met.
  • Integra Lifesciences
    Quality System Manager
    Integra Lifesciences Nov 2018 - Aug 2022
    Princeton, New Jersey, Us
    Responsible, coordinate, investigate and maintain Quality Management System activities and tasks such as CAPA, NC, Complaints and OOS in accordance to established policies and procedures defined by Integra QA Compliance Group to maintain the site operations in compliance with regulations and Corporate policies and procedures with quality management system standard ISO 13485 and MDASP requirements. Oversee and develop documentation/training System and Internal/External Audit Program.
  • Integra Lifesciences
    Qa Manager
    Integra Lifesciences Feb 2017 - Oct 2018
    Princeton, New Jersey, Us
  • Derma Sciences
    Qa Manager
    Derma Sciences Feb 2014 - Feb 2017
    Princeton, New Jersey, Us
    Responsible for Quality Assurance operations, compliance, and documentation of activities to support GxP activities. As QA Manager, I also responsible for developing, maintaining, promoting and assuring Quality Systems are in alignment with global GxP, regulatory compliance requirements and current industry standards and guidance; responsible for supporting external and internal audits of quality systems (Vendor, contract Labs), batch record review and documentation/training management. As well as coordinate and lead diverse teams in evaluation of cGMP quality systems for API product supply.
  • Ohio Medical Corporation
    Quality Manager
    Ohio Medical Corporation Nov 2008 - Jan 2014
    Gurnee, Il, Us
    Responsible for Quality Management System (QMS) compliance and manage all company-wide, quality policies, procedures, processes, programs, and practices, to assure the company of continuous conformance with appropriate standards and regulations and to ensures all the company's products and services meet and exceed the customers' expectations. This is including Quality Assurance, Quality Control and Regulatory Affairs, ISO 13485 certification, and interaction with the FDA, Health Canada, Notified Bodies (EU) and/or any other corresponding regulatory agencies
  • Amvex Corporation
    Supplier Quality/Quality Control Manager
    Amvex Corporation Feb 2006 - Oct 2008
    Responsible for producing high quality, cost effective medical devices by maintaining quality standards, inspection and test methods, supplier quality and procedures for the organization. Assisting Quality Manager on QA, Regulatory Affairs, ISO certification and assist in regulatory inspections and customer & compliance audits.
  • Amvex Corporation
    Senior Quality Engineer
    Amvex Corporation Nov 2004 - Jan 2006
    Responsible for Providing Medical Device Quality Assurance technical expertise by participating in the day-to-day operation of the department as it relates to the design and manufacture of medical devices. This is including aids Production, Manufacturing and Design Engineering in develop product process to adherence to QS requirements, develop and implement procedures to assure compliance with Medical device regulations, assist in regulatory inspections and customer & compliance audits, assess CAPA to verify appropriate results were obtained and review Technical Publications, articles and abstracts to stay abreast of technical developments in the industry.
  • Amico Corporation
    Quality Control Supervisor
    Amico Corporation Nov 2001 - Nov 2004
    Richmond Hill, Ontario, Ca
    Responsible for monitoring production, and coordinating the activities of QC workers who are involved in inspecting materials and ensuring that they meet the quality standards specified by the company.

Patrick Tam Skills

Quality Management Quality Engineering Quality Auditing Capa Iso 13485 Fda Gmp Quality System Fda Fmea Quality Control Medical Devices Root Cause Analysis Etl Csa 2010 European Union Occupational Health Ppap Quality Assurance Technical Files Medical Device Directive Internal Audit External Audit Risk Management Risk Assessment Risk Analysis Product Safety Patient Safety Gd&t Gdp Gmp Iso 14971 Ce Marking Gxp Lean Manufacturing 5s Adverse Event Reporting Adverse Events Hydraulic Systems Pneumatics Robotics Iso Regulatory Affairs Manufacturing Product Development Supplier Quality Process Improvement Validation Continuous Improvement Cross Functional Team Leadership

Patrick Tam Education Details

  • Centennial College
    Centennial College
    Electro-Mechanical Engineering Technology

Frequently Asked Questions about Patrick Tam

What company does Patrick Tam work for?

Patrick Tam works for Sterling Industries

What is Patrick Tam's role at the current company?

Patrick Tam's current role is Corporate Quality Manager - Multi Site.

What is Patrick Tam's email address?

Patrick Tam's email address is ch****@****ail.com

What is Patrick Tam's direct phone number?

Patrick Tam's direct phone number is (609) 514*****

What schools did Patrick Tam attend?

Patrick Tam attended Centennial College.

What skills is Patrick Tam known for?

Patrick Tam has skills like Quality Management, Quality Engineering, Quality Auditing, Capa, Iso 13485, Fda Gmp, Quality System, Fda, Fmea, Quality Control, Medical Devices, Root Cause Analysis.

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