Post-Market Surveillance Engineer M/F/X

Job title:

Post-Market Surveillance Engineer M/F/X

Company

Tissium

Job description

DESCRIPTION OF THE COMPANYTissium is a mission-driven 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.Tissium’s technology is based on research and intellectual property from the laboratories of Professor Robert Langer (MIT) and Professor Jeffrey M. Karp (Brigham and Women’s Hospital), who co-founded 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.RESPONSIBILITIESThe Post-Market 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 Post-Market 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 risk-based 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 problem-solving 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 a dynamic 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 quality-related role within a regulated environment.
• You are proficient in handling 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 and other standards and regulations applied to our business.
• Excellent communication skills (written and verbal) in English.

WHY JOIN US

• Evolve in a pleasant and stimulating environment, with a work culture that values acting with urgency, a willingness to take risks, a desire to learn, an ability to challenge norms, and a capacity to operate within a dynamic range;
• Scalable career paths: at Tissium, we invest in the training and professional development of our employees, with programs adapted to their needs. We believe in the importance of offering varied learning methods to allow everyone to flourish in their professional project.
• An opportunity to join an ambitious and innovative startup striving to address one of the most persistent medical challenges since the inception of surgical procedures.
• Join a MedTech company that is environmentally and socially committed, Environmental, Social and Governance (ESG) themes are anchored in our business model and as our business grows, we found it to be even more essential for us to strengthen and solidify our ESG strategy and commitments.
• Enjoy many benefits: Work-life balance | Possibility of teleworking | Attractive overall remuneration | Opportunities for internal or geographic mobility (2 sites: Paris, Boston and Industrial site : Roncq)
• An international work environment with team members from over 19 different nationalities, reflecting Tissium’s commitment to diversity and its inherent strengths.

HIRING PROCESS

• The journey starts with an interview with Talent Acquisition Manager (30 mins)
• Then a face-to-face (virtual) meeting with the Manager of the department you are applying to join (1 hour)
• For the very final round, you will be invited on-site for a final team and culture fit interview.

(In certain instances, you may be asked to provide us with professional references, including contact details.)Intrigued? We’d love to hear from you! Apply today — we’re 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 individual’s voice is heard, making our processes lightweight yet efficient.Founded in 2013, Tissium is a fast-moving medical device company dedicated to developing innovative tissue reconstruction solutions.We leverage our technology platforms to develop new innovative solutions in surgery for a positive impact on patients’ lives. We are headquartered in Paris, with a production facility in Roncq (near Lille) and an office in Boston.

Expected salary

Location

Paris

Job date

Sat, 16 Nov 2024 05:23:37 GMT

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