Join our Team
As our customer base and service portfolio continue to develop and grow, we welcome applications from experienced candidates looking to join our dynamic organisation.
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 medical technology industry, then a role as a Congenius Consultant could be your next rewarding career step. Get in touch to find out more about joining the team.
Current opportunities
Quality Assurance Manager Combination Products and Medical Devices (temp, 100%)
Reporting into our Head of Quality, Dr. Dirk Hüber
Your Responsibilities
- Act as the quality single point of contact for assigned device development or industrialisation projects for combination products and medical devices
- 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 & 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
- Fluency in English – written and spoken, is a must, German is a nice to have
- This contract is limited to one year with an option for extension
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 will benefit from flexible working hours in an exciting and versatile field of activity
- You will work in a company with a flat hierarchy and short decision-making processes
- You can expect a pleasant working atmosphere, with uncomplicated and collegial cooperation
- You will benefit from modern and attractive working conditions and development opportunities
- An attractive salary and very good social benefits round off the offer
To apply for this role, visit our LinkedIn jobs page.
Packaging Engineer for Secondary Packaging of Combination Products (temp, 100%)
Reporting into our Head of Quality, Dr. Dirk Hüber
Your Responsibilities
- Evaluate and develop new materials and/or alternate packaging materials, secondary packaging solutions, or packaging systems based on product, regulatory, business, or technical requirements for combination products
- Communicate key risks/challenges to stakeholders as necessary
- Author technical documentation to support packaging development organisation (e.g., requirements documents, risk assessments, protocols/reports)
- Integrate industrialisation requirements for high-volume products into packaging development
- Support packaging verification activities (qualification project plan, qualification protocols, qualification reports, and qualification summary reports)
- Advise and consult customers and suppliers (take indirect leadership as appropriate)
- Interact with suppliers and CMOs; willingness to travel up to 10% nationally and internationally
Your Skills & Experience
- Master of Science (MSc), preferably with an engineering degree in packaging, materials science, or a related field
- Professional background: 5+ years of experience in medical device regulation and package engineering within the pharma or medical device industry
- Experience in project management in the pharma industry
- Strong experience in budget planning, project timeline planning, and problem solving
- Knowledge of ISO 13485
- Knowledge of ASTM D4169, ASTM D7386, and container closure integrity testing
- Hands on working experience in GMP environment and authoring technical documents
- Confident in presenting, networking, and building relationships
- Team player who works efficiently and flexibly within interdisciplinary teams
- Decision maker, taking the lead where appropriate and necessary
- Fluency in English – written and spoken, is a must, German is a nice to have
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 will benefit from flexible working hours in an exciting and versatile field of activity
- You will work in a company with a flat hierarchy and short decision-making processes
- You can expect a pleasant working atmosphere, with uncomplicated and collegial cooperation
- You will benefit from modern and attractive working conditions and development opportunities
- An attractive salary and very good social benefits round off the offer
To apply for this role, visit our LinkedIn jobs page.
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