Quality Engineer

Job content

Passionate by biomedical engineering, you seek to join a fast-moving and research oriented company? You want to develop your career in Quality and Regulatory topics? Joining a dynamic, entrepreneurship and human organization is a primary motivation for you?

Job Purpose

We are seeking for a person to be part of a new start-up adventure. She/He will join the QA/RA Team and provide support to an ever growing work including CE marking as well as FDA process to place on the market their first class III neurostimulator.

Your role

Part of a small team, you and your team are involved in the update and the improvement of the Quality System based on the ISO 13485 (see job purpose). You are also involved on regulatory topics and you ensure a good communication with R&D team in order to develop products respecting regulatory and quality requirements.

Your responsibilities

• You provide on-going guidance in the proper implementation of the Quality Management System
• You identify opportunities for improvement of the Quality Management System
• Set up and maintain control and document procedures by ensuring all specified quality and documentationrequirements
• You write SOPs
• You perform gap analysis (standards and regulations, guidance)
• You manage CAPA and non-conformity process
• You perform internal audits
• You support the revision of technical documentation in order to assure its regulatory & quality compliance
• You assist the coordination of complaints investigation and complaint handling
• You support of the different steps for new device development: risk assessment, design control, labelling, etc.

Requirements

The successful candidate will have the following skills, knowledge, experience and qualities:

BACKGROUND

· University or High School Degree in Electronics Engineering, Biomedical Engineering, Applied Mathematics Engineering or similar applicable to the job description

· 1 or 2 years of relevant experience in medical devices QA functions

HARD SKILLS

· Good understanding of medical devices regulatory environment (MDD 93/42, MDR) & Good knowledge of medical devices quality assurance (ISO 13485) and relevant standards

· Good verbal and written communications skills in English and French (speaking work environment)

SOFT SKILLS

· Passionate about Biomedical Engineering, medical devices, technology and innovation

· Thorough, hands on approach

· Showing attention to details, with the ability to cope with the complexities and tensions of a rapidly developing programme

· Able and willing to work and evolve in a start-up atmosphere

· Organizational, flexibility, adaptability and responsiveness skills

Our offer

Synergia Medical offers a friendly, dynamic and ever evolving start-up atmosphere and team. You would have the chance to get involved in the company evolution and in the full chain of development, from specifications to clinical investigations and market and, ultimately, help improve people’s life.

Synergia Medical offers a full-time open-ended contract and good salary package and flexible advantages, and trainings.

How to apply ?

If you are interested in this challenging opportunity, please address your application (CV and short motivation text) by email to info@synergiam.com

Only selected candidates will be contacted.