Patrick Tam Email & Phone Number

Markham, On, Ca

Woodbridge, Ontario, Ca

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.

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.

Princeton, New Jersey, Us

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.

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

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.

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.

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.