Position Description

Validation Program Engineer (Medical Product/13485)
Job Code 15559
Division GMP TECHNOLOGIES (S) PTE LTD (EA Licence:11C3793)
Job Placement Location Singapore
Apply Now

Job Summary:

  1. Responsible for quality engineering support for the manufacturing of medical device throughout the supply chain.
  2. Focuses on validation process review and risk management.
  3. Using statistical techniques and quality tools to ensure medical devices are made in compliance with QMS, international & industry standards, regulatory requirements and customer requirements.

 

Responsibilities:

  • In charge of risk management process, maintain risk management procedure and risk management framework. Responsible for all risk assessment report review, review risk management plan/report for all product platforms.
  • Manage multiple projects to provide review on technical validation of analytical tests, control systems, utilities and manufacturing processes.
  • Driving overall quality performance and compliance throughout the organisation by defining, implementing validation program.
  • Develop and communicate expectations for quality performance, continuous improvement, quality systems, process controls infrastructure for critical sustaining parts and new products.
  • Drive manufacturing process improvement project to resolve quality, yield or cost reduction initiatives
  • Provide guidance or training on use of risk management tools and techniques, data analysis, sample size determination, problem solving methods and statistical control techniques.
  • Execute projects/other duties assigned by supervisor

 

Requirements:

  • Degree qualified in Science/Engineering major, with 3+ years of experience in Medical Device/Pharmaceutical industry handling validation process projects
  • Strong in Quality Assurance principles
  • Advanced skills in Validation principles / industry standards
  • Able to communicate & guide/train on validations, risk assessments and statistical techniques
  • Knowledge of ISO9001, ISO13485/21 CFR Part 820

 

We regret that only shortlisted candidates will be notified.

GMP Technologies (S) Pte Ltd   |   EA Licence: 11C3793   | EA Personnel:  Tan Wai Peng  |   Registration No: R1104671

Contact Person: Tan, Wai Peng - Reg No:R1104671 (waipeng.tan@gmprecruit.com)

Back Apply Now