Manager, Quality Systems (Medical Devices)

Location Singapore, Singapore
Job reference BBBH83108_1571369960
Salary Basic + AWS + Bonus
Consultant name Alexis Bo Zhuang Mian
Consultant email alexis.bo@experis.com.sg
Consultant contact no. 65515307
EA License No. 02C3423
Consultant Registration No. R1872731


Responsibilities

  • Serve as the subject matter expert for the overall quality system
  • Provide regulatory compliance advice to resolve quality management system issues
  • Serve as a focal point for Quality matters, including corrective action and continual improvement activities
  • Formulate and recommend policies, strategies, tactics, goals and objectives relating to Quality and regulatory compliance
  • Drive the implementation of Quality and Regulatory strategies
  • Evaluate the effectiveness and compliance of the Quality Management System
  • Serve as a resource for statistical information in the Quality and Engineering areas
  • Facilitate Management Reviews and present executive summary
  • Where appropriate, facilitate the non conformance process, CAPA activities, supplier quality, complaint handling and audit program to meet all procedural and regulatory requirements
  • Ensure the effectiveness, execution and timeliness of Internal Audits. Report the results to executive management during Management Reviews
  • Facilitate external audits from outside agencies


Requirements

  • You have at least 5 years of regulatory experience in medical device industry
  • You have good knowledge of quality and reliability design principles
  • You are familiar with 21 CFR 820 Quality System and ISO 13485 regulations
  • You have experience in FDA approval processes



Interested applicants please send your resume to alexis.bo@experis.com.sg

Bo Zhuang Mian
R1872731


Manpower Staffing Services (S) Pte Ltd
02C3423

Alexis, Zhuang Mian Bo EA License No.: 02C3423 Personnel Registration No.: R1872731

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