Information sur la société
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.
Within the Quality Assurance Department, we are looking for a CUSTOMER QUALITY ENGINEER (M/F)
Description du poste
Fonction : CUSTOMER QUALITY BIOMEDICAL ENGINEER (M/F)
Secteur : Industrie
Région / Pays : Ile de France / France
Lieu : Clamart (92)
As Customer Quality Engineer, you will perform, either autonomously or through coordination with R&D department, all the technical investigation/analyses associated with worldwide events related to Complaints.
You will be located in the Clamart site.
Your role will report to the Manager, CRM Customer Quality.
- Evaluate priority level of reported complaints and manage them accordingly to ensure patient safety and customer satisfaction,
- Perform the relevant analyses needed for the investigation,
- Drive and coordinate the investigations with different global functions (Research & Development, Quality Engineering, Operations,) and suppliers when applicable,
- Provide patient management recommendations when applicable,
- Record adequately all investigations conducted,
- Write investigation reports,
- Provide customer with investigation report when applicable, and close out complaint in the system,
- Ensure timeliness of complaints closure,
- Collaborate in the preparation of communications and reports to the Competent Authorities in case of reportable events,
- Assist in launching and monitoring Field Safety Corrective Actions, as appropriate,
- Contribute to the continuous Quality Improvement Process (through the CAPA process),
- Share the Voice of the Customer and communicate within the internal organization customer needs and requirements,
- Ensure release of the Product Performance Report semi-annually,
- Participate to the review of product labelling,
- Update procedures, as necessary,
- Collaborate to manage and follow up the department related KPIs.
These tasks require a lot of rigor and attention to details, as well as the ability to handle confidential and sensitive information.
The right candidate will be able to ensure patient safety, continuous product quality improvement and regulatory compliance, by:
- prioritizing the complaints assigned to him/her,
- partnering with R&D, Operations and other Departments
- delivering thorough and timely complaints investigations
Profil du candidat
B.S. or M.S. degree in engineering or related scientific discipline (Ecoles Centrales, Ecoles des Mines, Imperial College London, UTC, etc.)
Biomedical or Electronic Engineering preferred
Entry level applicants (0-2 years of experience) are welcome to apply; 3-5 years’ experience in R&D or as field application engineer is a plus
Electronic and/or biomedical background
Knowledge and Skills
- Fluent in English (written and spoken)
- Very solid knowledge of Excel
- Good statistical skills
- Excellent problem solving, analytical and synthesis skills
- Strong organizational skills. Ability to manage priorities
- Good spoken & written communication skills
- Strong interpersonal skills. Ability to interface with technical resources and scientifically based teams.