Responsible to assure that manufacturing processes comply with the product specification and regulatory government agencies requirements.
Provide mechanisms for controlling the total quality and establish ways of evaluating the quality of products.
Participate on internal, inter-facility and vendor/supplier quality audits to determine the extent of compliance and effectiveness of operations, to documented policies, procedures, specifications, FDA and ISO requirements.
Assure that processes comply with specifications, Quality Systems Regulations and ISO standards.
Evaluate product/material discrepancies. PRB/MRB on time and implement corrective actions accordant.
Establish mechanism to evaluate, measure, monitor and/or quality in our products.
Provide check and balance to manufacturing/system changes submitted by manufacturing Engineers through evaluation/approval of Engineering change request/orders. Ensure update of manufacturing processes in order to reflect quality concepts and specification requirements.
Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
Ensure that processes comply, with a high confidence level, the tolerances stated on the product specification and drawings.
Apply statistical tools in order to assure that processes comply with the specifications.
Conduct failure investigations in order to initiate, stimulate, and assign corrective action. Issue written reports and update, accordingly.
Review and analyze quality trends with the manufacturing team. Analyze data based on trends, recommend actions for process, equipment and system improvement.
Work on product transfers activities and actively participate in product qualifications and validations of equipment and processes.
Perform risk assessment activities with reliability for product quality risks.
Bachelor degree qualified
Minimum 3-4 years of relevant experience related to manufacturing of small electro/mechanical devices, preferably in a quality assurance or test-related capacity.
Understanding of Statistical Process Controls is an added advantage
Proficient in use of Minitab software is preferred.
Knowledge of ISO13485 and FDA requirements (21CFR Part820) is preferred.
Some project management experience nice to have
To apply, please click "Apply Now" or visit www.gmprecruit.com and search for job reference: 18961
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
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