Head of Site Quality

Contract: CDI, permanent
Location: Roncq (59), France

At TISSIUM, we are creating the future of tissue reconstruction. Our team pushes the limits every day to design next-generation products based on our platform of biomorphic programmable polymers. We are disrupting the field of surgery, both open and minimally invasive, to positively impact the lives of patients.

We are actively looking to recruit a Head of Site Quality to be part of Tissium’s Development Factory. This person will manage and improve all of the production site quality related system and activities to ensure that:

  • The QMS is in compliance with all applicable standards and regulations;
  • All production activities are in compliance with the company’s QMS;
  • Provides Quality Assurance (QA) leadership;
  • Batch release is performed according to company’s policies and procedures.

DUTIES & RESPONSIBILITIES

  • Manages continuity and compliance of the QMS to applicable standards and regulations.
  • Ensures application of the QMS for all activities on Tissium’s production site.
  • Provides Quality Assurance (QA) leadership;
  • Ensures compliance with the QMS for all production activities by:
    • Ensuring an adequate QC strategy is in place where adequate quality control
      methods are used and only conforming products are released;
    • Ensuring that the system and organization in place are designed to efficiently
      manage inventory, including adequate identification and traceability;
    • Ensuring that production documentation is adequate.
  • Establishes and manages the production site’s metrology strategy.
  • Provides guidance on process quality requirements and risk management to the teams on the production site and any other involved parties (i.e. subcontractors).
  • Acts as the medical device vigilance correspondent back-up.

QUALIFICATIONS & SKILLS

  •  Engineering Degree or equivalent;
  • A proven experience in aseptic production processes is a must;
  • Ten years minimum of experience in Quality in a medical device or a life science company and in a production environment;
  • Working knowledge of EU medical device regulation 2017/745, ISO 13485, and FDA (FDA 21 CFR part 820) regulations;
  • Auditing experience;
  • Excellent communication skills (both oral and written) in English;
  • Competent in interactions with executive management, regulators and suppliers.

COMPETENCIES & PERSONAL ATTRIBUTES

  • Autonomous and detailed oriented;
  • Dynamic and proactive;
  • Able to understand complicated processes and understand the associated documentation needs;
  • Disciplined and very well organized;
  • Persuasive and diplomatic.

The Head of Site Quality will report to the Chief Development Officer. The position is based in Roncq (near Lille), France. To apply to this position please email your CV to jobs@tissium.com; REF202009-002