Congenius provides tailored expertise and leadership to global firms, established SME`s and aspiring start-ups in the medical device, IVD and pharmaceutical industry. If you enjoy working with a diverse range of people across a broad range of projects and are passionate about making a positive contribution to the MedTech industry, then joining our dynamic team could be your next rewarding career step.

**Your Responsibilities**

- Act as the quality single point of contact for assigned device development or industrialization projects for combination products and medical device
- Ensure adherence to applicable design control and risk management requirements
- Collaborate across functions to ensure robust quality at the interface between the drug product and device component within the combination product
- Develop and deploy risk management plans and reports; actively participate in and facilitate FMEAs
- Define specifications, including the drug product–component interface
- Drive investigations and change control assessments
- Represent the department at quality and change review boards
- Advise and consult customers and suppliers (take indirect leadership as appropriate)

**Your Skills and Experience**

- Bachelor of Science (BSc) in life sciences discipline or chemical/mechanical engineering
- Professional background: 5+ years of experience in device quality or device development within the pharma or medical device industry
- Experience in project management in the pharma industry with tools Six Sigma / DMAIC is preferred
- Hands on expertise in applying risk management concepts and tools, and deploying design control for combination products
- Sound knowledge of cGMPs and relevant international regulatory requirements (QSR; MDR; ISO13485, etc.)
- Confident in presenting, networking, and building relationships
- Team player who works efficiently and flexibly within interdisciplinary teams in global environments
- Decision maker, taking the lead where appropriate and necessary
- Fluent in English - written and spoken, German is a nice to have
- This contract is limited to one year with an option for extension

**Your Benefits**

- You will work in the Basel area for an ambitious, dynamic small company in the medical technology sector with a very good working atmosphere
- You benefit from flexible working hours and an exciting and versatile field of activity
- You work in a company with a flat hierarchy, short decision-making processes
- You can expect a pleasant working atmosphere, an uncomplicated and collegial cooperation
- You benefit from modern and attractive working conditions and development opportunities
- An attractive salary and very good social benefits round off the offer