Quality and Regulatory Assurance Manager

vor 3 Wochen

Bern, Schweiz CSEM SA Vollzeit

**Engineer**:
**Quality and Regulatory Assurance Manager (F/H) 100%**:

- 100%- Unbefristet- Bern / Neuchâtel**Facing the challenges of our time**

Help us grow and be more impactful

**Our “System” Business Unit **based in Neuchâtel/Bern, Switzerland, is currently looking for a an experienced: Quality and Regulatory Assurance Manager.

**Your mission**

In close partnership with the Business Unit Quality Manager and working with the different Groups of the Digital Health research activity and business stakeholders, you will be responsible for managing the quality assurance activities of our medical device development projects, working closely with our engineering teams and our clients to ensure that all regulatory and quality requirements are met. You will also support the BU-QM for the maintenance of our ISO 13485 and ISO 9001 certified Quality Management System and several related quality tasks.

**Your responsibilities**

Your role will include the following main responsibilities:

- Develop and maintain the BU Quality Management System to ensure compliance with ISO 13485, ISO 9001 and related regulations
- Develop and manage project plans for quality assurance activities
- Ensure that all quality assurance activities are completed on time and within budget
- Work closely with clients to understand their quality requirements and ensure that they are met
- Conduct and lead risk management activities for medical devices
- Work with engineering and product development teams to ensure that design controls are met
- Participate and/or lead internal audits to ensure compliance with quality standards
- Participate and/or lead external audits from our clients, and also from competent authorities regarding the BU’s ISO 13485 certification
- Plan and conduct new collaborators and continuous internal trainings
- Keep informed about the latest quality and regulatory standards
- Serve as the primary point of contact with competent authorities and clients regarding quality matters

Place of work will be **Bern and Neuchâtel**, with the plan to be located **100% in Bern** in a few months.

**Your profile**

**Know-how**
- Master or PhD degree in Electrical Engineering, Computer Science, Life Sciences, or a related field
- 5+ years of experience in medical device development and quality assurance
- Very good knowledge of ISO 13485, ISO 14971, IEC 60601 and related standards
- Knowledge of IEC 62304, EN 62366 and ISO 14155 is a plus
- Knowledge of the European Medical Device Regulation, with FDA regulation a plus
- Experience in vital signs monitoring (ECG, PPG, ) and active medical devices
- Advanced studies in quality, regulatory and clinical affairs would be an asset
- Auditor/Lead auditor certification is a plus
- Fluency in English is a must; fluency in French and/or German, knowledge of the other language is a plus

**Interpersonal skills**
- Passionate about improving digital healthcare through innovative medical device development with the ability to convey a good quality culture
- Excellent listening skills and ability to communicate within a team
- Strong problem-solving and analytical skills
- Customer orientation as well as excellent communication skills
- Clear result and solution-oriented approach
- Natural curiosity and ability/interest to work independently and manage complex multidisciplinary projects.

**CSEM mission and values**

Our mission is the development and transfer of innovative technologies to the Swiss industry and our strength is the excellence of our people who are passionate about 550 passionate specialists dedicated to innovation and technology transfer. We believe that strong values support the successful development of our organization as well as the harmonious and balanced development of all our employees.

**We are**
- A unique place between research and industry at the cutting edge of new technologies
- An innovative, non-profit, and employee-driven company
- A dynamic, multidisciplinary, and multicultural environment
- A solar team focused on enabling solutions to energy challenges for a sustainable world
- being part of a passionate community
- incredible flexibility, attractive working conditions, and great opportunities of development
- benefit from a **management style based on trust & feedback** and that **favors a work-life balance**

We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity.

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