Employment Type : 1 Year Contract , Renewable
The Quality Engineer provides support for Quality Operations to ensure product safety and performance. This role involves executing, maintaining, and improving quality operations procedures, including the management of incoming materials, in-process inspections, outgoing product inspections, and environmental monitoring for the serial production of components and products at BIOTRONIK Singapore. Additionally, the Quality Engineer ensures that manufactured components and products meet BIOTRONIK's specifications, comply with cGMP guidelines, and adhere to quality system standards. The role also requires maintaining communication with relevant Quality departments and collaborating with BIOTRONIK AG (BIO-CH).
Your Responsibilities
· Enforce and maintain quality operation procedures relevant to the production site, including process validation, non-conformance management, trending, and DMAIC.
· Collaborate with in-house microbiologists and external testing laboratories to plan, coordinate, and review testing, analysis, and reporting.
· Conduct incoming inspections of materials.
· Generate and review reports on quality issues and change controls.
· Apply Six Sigma principles and a least-burdensome approach to quality topics.
· Ensure the safety and performance of products manufactured at the site.
· Contribute to continuous improvement initiatives and manage CAPA (Corrective and Preventive Actions).
· Provide training on quality-related topics.
· Maintain contact with suppliers and service providers.
Your Profile
· At least a Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or a related field.
· One to two years of experience in a quality role within a regulated environment, such as the medical devices or pharmaceutical industry.
· Knowledge and experience in quality techniques, including Six Sigma methods such as DFSS, DMAIC, DoE, and FMEA.
· Familiarity with cGxP regulations, including ISO 13485 and FDA 21 CFR 820.
· Understanding of statistical methods and their applications in quality control.
· Proficient in English, both orally and in writing.
· Proficient in Microsoft Office and SAP.
