MicroPort CRM - Quality Systems Leader (M/F)
LivaNova PLC
France-Clamart
il y a 11j

Description

MicroPort Scientific Corporation is a leading medical device company with business focusing on innovating, manufacturing, and marketing high-

quality and high-end medical devices globally. With a diverse portfolio of products now being used at an average rate of one for every 15 seconds in thousands of major hospitals around the world, MicroPort maintains world-

wide operations in a broad range of business segments including Cardiovascular, Orthopedic, Endovascular, Neurovascular, Electrophysiology, Surgical Management, Diabetes Care and Endocrinal Management, and others.

MicroPort is committed to its vision of being a patient oriented global enterprise, improving and reshaping patient lives through application of innovative science and technology.

MicroPort CRM develops, manufactures and markets products for the diagnosis, treatment and management of heart rhythm disorders and heart failures.

  • CRM products include high-voltage defibrillators, cardiac resynchronization therapy devices and low-voltage pacemakers. MicroPort CRM has approximately 1000 employees with operations chiefly in Clamart, France;
  • Saluggia, Italy; and Santo Domingo, Dominican Republic.

    Quality Systems Leader (M / F)

    The Quality Systems leader is primarily responsible for supporting QA / RA solutions in place within the CRM organization from a Quality / Regulatory perspective and for ensuring validatation of changes of the processes managed by these QA / RA solutions.

    Essential Functions :

    The Quality Systems leader will support QA / RA solutions from a Quality & Regulatory perspective and will develop validation strategy when necessary, in accordance with quality / regulatory requirements.

    He / She is responsible for building and maintaining expertise on the QA / RA portfolio for the Quality and Regulatory functions for CRM.

    He / she supports other departments to ensure that QA / RA Tools are developped and maintained in accordance with the regulatory requirements and in collabration with IT department.

    This includes the following activities :

    Support and maintain QA / RA systems and processes in collaboration with IT :

  • Support the Customer Quality team in charge of complaints management, as needed (Reliance EtQ solution)
  • Support the Quality Documentation control team, as needed (MasterControl solution)
  • Support the Quality Engineering teams with the development and the maintenance of specific forms used to manage the QMS
  • Support other departments, as needed (BPCS, MES, Other tools used by Operations and R&D)
  • Assess and ensure compliance with of system solutions with regulatory requirements
  • Develop associated CRM policies and SOP as needed and maintain the QMS accordingly; train personel on these SOPs.
  • Perform or aid in the analysis, requirements specification, design, and implementation of new / modified systems for the Quality & Regulatory functions :

  • Work with project teams to assist with the validation and testing of systems (including creating and executing test scripts, developping validation plans and performing risks assessments);
  • Prepare and / or review validation documentation (plans, protocols, test suites, reports, etc.);
  • Support and maintain the UDI process including interfaces with database (e.g. EUDAMED, GUDID)

    Keep awareness of evolving regulatory requirements and technology developments for the specific business processes and influence the IT stakeholders and vendors in addressing these evolutions in the most efficient way.

    Other duties as required.

    Education and Experience

  • Degree or Diploma in Science, IT or Quality related discipline for the healthcare industry or equivalent
  • Minimum 5 years of directly related experience in Quality Assurance, preferably in the medical device or other regulated industry
  • Knowledge and Skills

  • Fluent in English (written and spoken)
  • Excellent written and verbal communication skills at multiple levels and across technical disciplines
  • Ability to plan for short and long term with proven high quality results
  • Ability to generate and monitor project / quality plans for multiple workstreams of IT and non-IT implementations
  • Sound knowledge on Quality Management Systems and the international and national regulations and standards such as 21 CFR820 and ISO 13485
  • Strong background in validating systems in an FDA regulated environment.
  • Deep knowledge on QA / RA systems and products used in Quality Systems including Complaint Handling, 21 CFR Part 11 Compliance, HIPAA / PHI, HL7, PLM, Doc Management, and e-submissions.
  • Sound knowledge of SQL and Excel
  • Ideally, experience with Quality Systems in the medical device industry.
  • Experience with software validation.
  • Highly detail oriented, well organized, and able to coordinate multiple projects simultaneously.
  • Strong analytical, problem solving and conflict resolution skills.
  • Energetic, motivated, service-oriented, and be able to multi task.
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