- Global Medical Devices MNC
- Working Location: East
- 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.
- Support other Quality Engineer improvement and quality activities as needed.
- May provide guidance and assistance to less experienced engineer (eg. Quality Engineer I)
- 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
- Min Bachelor’s Degree in Engineering qualification is required
- At least 4 years of relevant experience related to manufacturing of small electro/mechanical devices, preferably in a quality assurance or test-related capacity.
- Highly preferrable with project transfer/validation experiences in healthcare industry
- 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.
- Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience.
- May have practical knowledge of project management
To apply, please visit to www.gmprecruit.com and search for Job Reference: 18938
To find out more about this opportunity, please contact Alexandra at: firstname.lastname@example.org
GMP Technologies (S) Pte Ltd | EA Licence: 11C3793 | EA Personnel: Alexandra Calingo | Registration No: R1101491