Senior RampD Quality EngineerMFX

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 Senior R&D Quality Engineerwill be responsible for qualityassurance (QA) activities and documentation associated with new development and design changes to ensure compliance with the quality system andparticipating as a stakeholder in the design process to ensure product specifications and development activities are aligned with the organizations quality objectives.

This individual will provide oversight and generate quality documentation to ensure meet QMS compliance.

As part of a project team the R&D Quality Engineer will be responsible for Quality assurance input to and review of design specifications Supplier Qualification Manufacturing Quality Plan Risk Management Activities Design Verification and Validation Review and Audit Design History Files for compliance.

Duties & Responsibilities

TheSenior R&D Quality Engineerhas the following key responsibilities within the organization:

• Represent Quality on product development teams as responsible individual for ensuring compliance with company quality and applicable regulatory requirements and standards.
• Lead effort and ensure completion of Risk Management activities for new and/or modified products and processes authoring risk management plans and reports facilitating risk assessment activities.
• Work with Operations and R&D to develop manufacturing quality plans and set quality standards for new and/or modified products and processes to ensure a high level of product quality.
• Develop and implement traceability programs for new products and modified products
• Monitor compliance to design control processes and procedures
• Review and provide input for design verification and validation protocols and reports ensuring compliance with the quality management system.
• Provide input to design and manufacturing documentation including material specifications drawings inspection procedures and manufacturing procedures to ensure that the resulting products can be adequately manufactured and tested.

• Participate in supplier selection process and implement appropriate supplier quality controls during the development process
• Provide post release input from the quality system (nonconforming material reports yield rework) or external sources (customer complaints) for post release design and development activities.

The employee shall applicate all regulatory requirements in place at TISSIUM by applying TISSIUM Quality Management System documentation.

REPORTING LINE

This job will report tothe Director of Quality and will work closely with Product Development Technical Service Manufacturing Regulatory Operations and Quality.

YOU WILL LOVE THIS JOB IF

• You have strong written mathematical collaboration communication skills
• You are ableto generate internal quality documentation such as quality plans standard operating procedures and inspection procedures.
• You have excellent organizational skills as well as time management skills (essential for project work).
• You are selfmotivated and able to balance multiple priorities and tight deadlines with minimal supervision.

YOUR BACKGROUND

• Bachelors degree in science or engineering.
• 510 years Quality Assurance and/or design and development experience.
• Ability to generate internal quality documentation such as quality plans standard operating procedures and inspection procedures.
• Preference for Six Sigma certification.
• Experience using quality tools and statistical programs (e.g. risk assessment (FMEA) experimental design (DOE) and statistical process control (SPC) is required.
• Demonstrated working knowledge of 21 CFR 820 (Quality Systems in Medical Devices) ISO 13485 ISO14791 and other medical device related standards.

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 transportation expenses;
• 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 technical interviewor business case to validate your practical jobrelated skills (1 hour)
• For the very final round you will be invited to an onsite interview to meet other teams in Tissium for a team and culture fit interview.

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.