Quality Management Director 100%
Modum is combining blockchain and IoT technology to make the monitoring of supply chains more efficient and transparent. With our award-winning solution MODsense, we enable a uniquely easy way to collect temperature data of medicinal shipments across their supply chain. This helps our customers in the pharma industry to meet regulatory obligations and internal quality requirements. In addition we offer our customers blockchain and machine learning based solutions to leverage the collected data for business process automation across their supply chain ecosystem.
modum.io is made up of a talented team located in Technopark, Zurich that has maintained itself as a fast-paced, dynamic, customer-centric and high-performing group. Together, we work collaboratively to design and deliver the best solutions to digitalize the supply chains of our customers as a basis for our long-term growth. We are looking for like-minded people to join us and to take part in our exciting journey.
We are currently looking for a Quality Management Director to complete our leadership team.
In this attractive and demanding role, you will use your wide set of skills to help us build, manage and oversee our QMS, assuring the quality management of our organization as well as our suppliers, ensure legal compliance by owning regulatory affairs concerning organization and products as well as our quality commitments concerning our customers.
You should have solid experience in quality assurance and control functions, feel comfortable leading teams and be willing to work closely with our partners and auditors.
You should be eager to work in a start-up environment which is committed to quality and innovation and bring your unique set of talents to an enthusiastic and diverse team. Modum looks for team players and passionate personalities that are both collaborative and detail focused and who bring innovative ideas and attentive care to everything they do.
- Lead quality assurance at modum.io
- Responsibility for legal compliance of organization and offered solutions, quality management, internal processes, safety and and security
- Manage internal and external quality related projects to deliver in time and budget
- Build-up and manage quality assurance and quality control team
- Provide knowledge, support and training to relevant teams to operate within Quality Management System and regulatory guidelines, especially with regards to design and development of software and hardware products
- Represent modum.io externally regarding quality management and regulatory affairs
- Correspond with regulatory agencies / notified bodies including audits
- Represent modum.io in quality-related public events.
- Support sales team during customer workshops and customers who are validating modum’s solution
- Draft, negotiate and monitor quality assurance agreements with customers and suppliers
- Own internal quality management system
- Drive definition, implementation and maintenance of the quality management system across the value chain and ensure compliance with applicable standards
- Steer process design with process owners, formulate requirements, lead process risk and -opportunity management
- Implement and monitor post market surveillance processes (deviations and complaints, adverse event handling) and ensure effective and timely resolution of CAPAs
- Maintain current knowledge of new and emerging regulations guidance and changes and determine potential impacts on processes
- Plan, manage and conduct internal and external trainings and audits
- Academic degree in a technical field or equivalent formation
- Minimum 5 years of experience with projects related to developing and implementing quality management systems as well as compliance assurance, and auditing in the medical devices, aviation, automotive, logistics or pharma industry
- Minimum 3 years of team leadership and people management experience
- Excellent project management skills with ability to manage several projects at once
- Particular and proven experience for qualification of products, suppliers, equipment and validation of processes and computerized systems
- Good knowledge of IT systems and digitalization processes, excellent MS Office skills
- Deep knowledge of relevant regulations, standards (e.g. ISO 9001/27001, EN 12830, CFR 21 part 11, WHO PQS) and GxP guidelines
- Demonstrated experience at corresponding with regulatory agencies
- Keen perception, distinctive capability to work cross-functionally
- Experience in supply chain logistics and pharma distribution is a plus
- Experience in the supply industry for electronics, components, manufacturing is beneficial
- Demonstrated ability to work structured and result-oriented in a fast-paced environment
- High degree of efficiency and motivation in work habits in a challenging, fast-paced environment.
- A team player with a hands-on approach who is ready to make an impact.
- Excellent communication in English and German, both verbal and written
- Eligible to work in Switzerland.
Interesting, challenging, and diverse roles with a stimulating learning curve.
Work with a talented and results-oriented team to deliver unique solutions that consider the latest in IoT and blockchain technologies.
Personal development opportunities, while shaping a well-funded company.
In our growing organization, your personal contribution will have measurable impact on the organization and its products.
An open, transparent, and inclusive team culture.
We are a diverse but tight-knit team that gets things done. We are accountable to one another for professional deliverables and to maintain a fun work environment.
HOW TO APPLY
Please apply to firstname.lastname@example.org with a CV and cover letter, each attached in PDF format. Please include the job title in your subject line.