Quality Assurance Engineer for New Product

il y a 1 mois

Paris, France Tissium Temps plein

**DESCRIPTION OF THE COMPANY**:
Tissium 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).

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 **Quality Assurance Engineer for New Product Development (NPD)** will be responsible for quality assurance (QA) activities and documentation associated with new development and design changes to ensure compliance with the quality system and participating as a stakeholder in the design process to ensure product specifications and development activities are aligned with the organization's quality objectives.

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

As part of a project team, the 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**

The** **Quality Assurance Engineer for New Product Development (NPD)** has 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 (non-conforming material reports, yield, rework) or external sources (customer complaints), for post release design and development activities.**REPORTING LINE**

This job will report to the Director of Quality Assurance, 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 able to 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 self-motivated and able to balance multiple priorities and tight deadlines with mínimal supervision.

**YOUR BACKGROUND**
- Bachelor’s degree in science or engineering.
- 5-7 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,

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