- Salary: Undisclosed
- Work Type: Permanent / Full Time
- Min. Education Level: Degree
- Field of Study: Engineering Science
- Years of Experience: 3
- Skills: Quality Engineer, statistical analysis, manufacturing
Our client in medical and nursing industry is expanding their team in Singapore. We are looking for a Quality Engineer (Medical Device Industry) who will be responsible for providing expertise in the application of statistical methods including sample size determination, experimental design, data analysis, gauge RR, design and process capability and validation.
One of the world's largest medical technology company. They are the global healthcare solutions company committed to improving the lives of people.
As Quality Engineer (Medical Device Industry) your responsibilities will include but not limited to:
- Participate in the quality council from corporate and being the leader to represent MSO for this council.
- Work with Engineering and Manufacturing to ensure product meet specification and requirement.
- Evaluate, measure, monitor and/or quality in our products.
- Work on new product transfers and participate in the qualifications and validations of product/equipment and processes.
- Apply statistical tools in order to assure that processes comply with the specifications.
- Ensure compliance to audit findings in a timely manner.
- Quality Systems Regulations and ISO standards.
- Ensure accuracy and integrity of validation protocols, reports and documentation generated to meet regulatory authorities,
- Coordinate qualification and validation activities for all product and technology transfers.
- Focal point contact on statistical resources. Consult and partner across all functions and facilities.
- Provide statistical support expertise in areas such as sample size determination, DOE, data analysis, gage RR, Cpk, validation and other related areas.
- Serve as an organizational focal point for challenging statistical issues and analysis.
- Provide training in statistical methods, aligning to Corporate Statistical Resources.
- Develop, improve and deployment of policies and procedures related to the application of statistical methods and DRM practices.
- Develop and conducting training (DOE, Statistics, Process Validation/Control Protocols, Test Method Validation, Data Analysis, Minitab and other Statistical tools).
- Responsible for all aspects of process control with the specific objective of improving product quality.
- Leading the qualification/validation strategies for the facility
- Key expert in the Statistical Process Control and main point of contact spokesperson during the facility Audit inspection/investigations.
- Works and implements special improvement assignment/projects as assigned by Direct Supervisor.
The ideal Quality Engineer (Medical Device Industry) that we are looking for should have:
- Bachelor Degree in Engineering or equivalent
- 3 years' work experiences in engineering related (Manufacturing/Process/Quality Engineering functions) in a quality assurance capacity.
- Experience in experimental design, data analysis, sampling methods, process validation and process control.
- Statistical knowledge which include SPC, DOE, Gage RR and other advanced statistical tooling techniques.
- Possess and has demonstrated the ability in Statistical Process Control
- Experience in Lean Sigma Methodology, Problem Solving and Decision Making techniques.
- Proficient in the use of Microsoft Word, Excel, PowerPoint and Minitab.
- Continuous development and career advancement opportunities within the organisation.
To apply online please click the 'Apply' button below. For a confidential discussion about this role please contact Liza Samonte (Lic No. R1220128) on +65 6416 9881.