Quality System Engineer MFX

DESCRIPTION OF THE COMPANY

Tissium is a missiondriven medical device company founded in 2013 headquartered in Paris with a production facility in Roncq (near Lille) and an office in Boston. We are dedicated to creating a new era of body repair by leveraging our biopolymer platform to develop new innovative solutions in surgery for a positive impact on patients lives.

Tissiums technology is based on research and intellectual property from the laboratories of Professor Robert Langer (MIT) and Professor Jeffrey M. Karp (Brigham and Womens Hospital) who cofounded the company with Christophe Bancel (CEO) and Maria Pereira (Chief Innovation Officer).

We are developing polymers for atraumatic tissue repair in various applications. Today these polymers are used for structureless nerve repair hernia repair and cardiovascular sealing

Since our inception we have raised a total of 170 million euros. Our latest fundraising round which concluded in April 2023 resulted in 50 million euros in additional funding. This infusion of capital provides us with the necessary resources to finance the commercialization of our first products.

BACKGROUND

The Quality Systems Engineer is responsible for the development implementation and continuous improvement of the Quality Management System (QMS) to ensure product quality and compliance with standards ISO 13485 and 21 CFR part 820 and regulatory requirements. This role involves crossfunctional collaboration with engineering manufacturing and other departments to drive quality initiatives and foster a culture of quality throughout the organization.

RESPONSIBILITIES

The Quality System Engineer will ensure improvement and compliance of the QMS by:

• Establish and maintain QMS documentation including policies procedures and records.
• Ensure that the QMS complies with applicable regulatory standards
• Works directly with operating entities to provide process analysis oversight continuing to enforce requirements and meet regulations.
• Manage Document Control process including the management and administration of the Tissium Document control system.
• Leads audit and inspection preparation resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.
• Manage Internal audit program.
• Handle Quality System NC and CAPA resolution.
• Management of the QMS risk analysis
• Active participation in Management review by collecting data creating presentations recording minutes meeting and following up on action items.
• Define and Follow QMS KPI.
• Update and continuous improvement of the QMS (evaluate the needs for improvement of the different processes based on the risks: efficient QMS and compliance with the requirements)
• Active participation in the QMS simplification project
• Responsible to develop and implement a training process to train employee and new employees on QMS principles internal procedures and relevant regulatory requirement.
• Your biggest challenge will be to develop and promote a Quality Culture program through the organization.

REPORTING LINE

This job will report to the Quality Director.

YOU WILL LOVE THIS JOB IF

• You are dynamic and proactive;
• You are passionate about quality and health care products;
• You are a good communication;
• You are disciplined and very well organized;
• You area decisive and solutionsorientated individual with a track record of successful achievements and accomplishments in a qualityrelated role in a regulated environment;
• You are enthusiastic;
• You are able to handle multiple tasks accurately and efficiently

YOUR BACKGROUND

• Engineering Degree or equivalent;
• Minimum of 5 years experience in regulated environments specifically in Medical Device Company;
• In depth knowledge of ISO 13485 standards and 21 CFR part 820 regulations;
• Excellent communication skills (written and verbal) in English.

WHY JOIN US

• A work culture that values urgency a willingness to take risks a desire to learn an ability to challenge norms and a capacity to operate within a dynamic range;
• A competitive salary;
• 50% reimbursement of public transportation expenses or access to oursustainable mobility package
• The flexibility to work in Paris Roncq or a hybrid arrangement;
• An international work environment with team members from over 13 different nationalities reflecting Tissiums commitment to diversity and its inherent strengths;
• An opportunity to join an ambitious startup striving to address one of the most persistent medical challenges since the inception of surgical procedures.

HIRING PROCESS

• The journey starts with an interview with Talent Acquisition Manager (30 mins);
• Then a facetoface (virtual) meeting with the Manager of the department you are applying to join (1 hour);
• This will then be followed by a case study or business case to validate your practical jobrelated skills (1 hour);
• For the very final round you will meet other teams in Tissium for a culture fit interview (45 mins).

Intrigued Wed love to hear from you! Apply today were standing by for your resume!

We firmly believe that building a company for everyone requires a diverse team. Our organization values diversity and welcomes applications from individuals of all backgrounds. We do not discriminate against employees or applicants based on gender identity or expression sexual orientation race religion age national origin citizenship disability pregnancy status veteran status or any other differences. Our company culture prioritizes human interaction and ensures that every individuals voice is heard making our processes lightweight yet efficient.