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Engineer - Quality Control
Job summary
A medical devices company in Penang, Malaysia seeks a quality engineering professional to improve production processes and assure product quality. This role is suitable for fresh graduates or candidates with up to 2 years of experience, requiring a Bachelor's degree in Engineering. Candidates should possess knowledge of ISO 13485, analytical skills, and basic process improvement concepts. A commitment to quality and a willingness to work in a regulated environment are essential for success in this position.
Qualifications
- Fresh graduates or 0–2 years of experience in manufacturing or quality engineering.
- Knowledge of ISO 13485 and regulatory requirements for medical devices.
- Basic understanding of engineering principles and Lean/Kaizen concepts.
Responsibilities
- Coordinate activities for quality control inspection to meet standards.
- Involved in continuous improvement projects and coordination of activities.
- Analyse product specifications to recommend process and operation changes.
Skills
Education
Tools
Where applicable, follow established engineering principles to determine the sequence of steps or processes required to fabricate and assemble products that meet the organization's standards of quality and cost.
Where applicable, analyse product specifications, part drawings, and other engineering data to develop new production processes and develop recommendations for changes to working methods or operations sequence that will minimise risks, cost, and wastage; increase yields and productivity; and improve the quality and consistency of final products.
Where applicable, be involved in continuous improvement/kaizen/lean projects and meetings, and coordinate process improvement activities within the area of responsibility.
Where applicable, coordinate Verification Matrix establishment activities with the respective CoE.
Where applicable, update the holdback listing and initiate the NCIR/CAPA/CAPA request for holdbacks.
Where applicable, coordinate QS-Stat training for the site upon request and review/update SOP related to QS-Stat.
Where applicable, coordinate & develop URS for software validation within the area of responsibility.
Where applicable, coordinate evaluation of harmonizing amongst inline tests, IPQC, and FC to ensure an effective and cost-optimized quality control inspection.
Where applicable, coordinate activities related to time studies of processes within the area of responsibility.
Where applicable, coordinate activities related to measurement system analysis (MSA) of test, inspection, and measuring equipment within the area of responsibility.
Where applicable, train and coordinate activities related to test method verification/revalidation.
Where applicable, be involved in respective plant projects relevant to the area of responsibility, such as SPC implementation.
The job function listed is not exhaustive and shall include any responsibilities as assigned by the Supervisor from time to time.
Bachelor’s degree in Engineering or a related field.
Fresh graduates or 0–2 years of experience in manufacturing or quality engineering (medical device experience is an advantage).
Knowledge of ISO 13485, quality systems, and regulatory requirements for medical devices.
Basic understanding of engineering principles, process improvement, and Lean/Kaizen concepts.
Ability to read and interpret product specifications, part drawings, and engineering data.
Familiarity with inspection methods, measurement tools, and statistical analysis (SPC, MSA).
Proficiency in Microsoft Office; knowledge of QS-Stat or similar software is a plus.
Strong analytical and problem-solving skills.
Good communication and teamwork abilities.
Detail-oriented, organized, and committed to quality and safety standards.
Willingness to work in a regulated manufacturing environment.
* The salary benchmark is based on the target salaries of market leaders in their relevant sectors. It is intended to serve as a guide to help Premium Members assess open positions and to help in salary negotiations. The salary benchmark is not provided directly by the company, which could be significantly higher or lower.