Post-Market Surveillance 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.

RESPONSIBILITIES

The PostMarket Surveillance Engineer is a transversal position who will have the responsibility of the management of the Change Control and CAPA process being the key contact for other department involved in those processes. This position is also responsible for post market activities including Complaints handling Health Hazard Evaluation risk management Field action and will be the contact with customer service.

The PostMarket Surveillance Engineer will ensure improvement and compliance of the QMS by :

1. Change Control Process Management :

Act as the main point of contact for Change Control.

Improve the Change Control process.

Support compliance with regulatory requirements by maintaining and monitoring information related to problem statements impact assessment of the Change risk assessment action plan definition and tracking of timelines.

Establish measures to assess the efficiency of the process.

Lead the Change of Control Board.

2. CAPA Process Management :

Serve as the key contact for CAPA resolution.

Support compliance with regulatory requirements by maintaining and monitoring information related to problem statements root cause analysis corrections corrective and preventive actions risk assessment and tracking of timelines.

Collaborate with Engineering Operations and other functional groups to ensure quality performance.

Develop and conduct training sessions to improve CAPA handling.

Implement a riskbased approach in CAPA resolution which is crucial from an FDA perspective.

Establish measures to assess the efficiency of the process.

Lead CAPA committee meetings.

3. Complaint Process Management :

Handle complaints and document investigations including reviewing Risk Management files and Device History Records.

Engage with other departments to support complaint investigation and determine appropriate actions.

Ensure timely completion of complaints.

Prepare summary and trend reports for management evaluation.

Participate in Quality Management Reviews as requested.

Evaluate reportability to the Competent Authority (FDA).

Define and implement a Health Hazard Evaluation process until Field Action.

Establish a Product Safety Review Board to make decisions regarding the need for Field Action based on patient and regulatory risk approach.

Generate Post Market Surveillance reports by compiling inputs from various sources.

Manage Field Action activities if necessary.

Maintain contact with Customer Service.

4. Develop processes with Customer Service based in the US.

5. Collaborate with other supporting departments to resolve quality problems using established problemsolving methodologies and drive corrective and preventive actions.

6. Participate as a team member in the implementation of the 3PL solution related to product return product hold level 2 and recall activities.

YOU WILL LOVE THIS JOB IF

• You have adynamic and proactive nature.
• You are passionate about quality and healthcare products.
• You have strong communication skills.
• You are discipline and highly organized.
• You are able to make decisive decisions and focus on solutions.
• You are enthusiastic and motivated.
• You have a demonstrated track record of successful achievements and accomplishments in a qualityrelated role within a regulated environment.
• You are proficient in handling multiple tasks accurately and efficiently.

YOUR BACKGROUND

WHY JOIN US

HIRING PROCESS

In certain instances youmay be asked to provide us with professional references including contact details.)

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.