Quality Engineer, Vascular Intervention

1 week ago

Singapore BIOTRONIK SE & Co. KG Full time

Quality Engineer, Vascular Intervention

BIOTRONIK is one of the leading manufacturers of cardio
- and endovascular implants and catheters for cardiac rhythm management, electrophysiology and vascular intervention. As a globally active company headquartered in Berlin, Germany, we develop, produce and distribute high-quality medical products based on the latest technology and research. Our success is based on the competence and results-oriented cooperation of our employees.

**1 Year Contract, Renewable**

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 review testing, analysis and reporting
- Conduct incoming inspection for material
- Generate and review reports on quality issues and change controls
- 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
- 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
- Knowledge of statistical methods
- English and German/ local language is a plus

Location: Singapore | Working hours: Full-time | Type of contract: Unlimited

Job ID: 59776 | Contact: TUapm Recruiting VI |

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.

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