Quality Engineer, Vascular Intervention

Quality Engineer, Vascular Intervention

As one of the world´s leading manufacturers of cardio- and endovascular medical devices, BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries by its global workforce. The work of our committed, highly specialized, exceptionally skilled employees results in crucial advancements in the world of cardiology and changes the lives of patients every day.

The Quality Engineer is responsible to provide support to Senior Quality Engineer on quality related matters to ensure product safety and performance. The Quality Engineer shall support execution, maintenance, and improving quality operations procedures as well as quality responsibility of incoming material, in process/outgoing product inspection and environmental monitoring on serial production of components and devices for BIOTRONIK Singapore. The successful candidate ensures safety and performance of the manufactured components and products as per BIOTRONIK specifications under cGMP and quality system rules. He/She is also in contact with the relevant Quality departments and has to collaborate with both BIOTRONIK AG (BIO-CH).

Your Responsibilities

• Enforce and maintain quality operation procedures relevant for the production site, e.g. process validation, non-conformance management, trending, DMAIC
• Work with In house Microbiologist/external test lab on Planning, coordinate and oversee testing, analysis and reporting
• Conduct incoming inspection for material
• Generate and review reports on quality issues and change controls
• Apply six sigma principles and least burdensome approach in quality topics
• Ensure safety and performance of products manufactured at the site
• Contribute to continuous improvement and CAPA handling
• Training of quality relevant topics
• Contacts to suppliers and service providers

Your Profile

• Bachelor Degree in Mechanical, Biomedical, Engineering or equivalent
• At least two years’ work experience in a quality function in regulated environment, ie. medical devices or pharmaceutical industry
• Knowledge and experience of quality techniques: Six Sigma methods such as DFSS, DMAIC, DoE, FMEA, etc.
• cGxP Know-How incl. regulations ISO 13485, FDA 21 CFR 820, MDD 93/42/EEC
• Knowledge of statistical methods
• English and German/ local language is a plus (In order to liaise with German speaking associates).

What we offer

• being encouraged to think and act entrepreneurially
• working in global teams and projects
• developing yourself professionally

Are you interested? Please apply online through our application management system! We are looking forward to welcoming you.

Location: Singapore| Working hours: Full-time

Apply now under: www.biotronik.com/careers

Job ID: 27001 | Contact: Human Resources

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, disability status, protected veteran status, genetic information, or any other characteristic protected by law.