Customer Quality Engineer
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.
The main products involved are: implantable cardiac defibrillator systems, pacemaker systems, cardiac resynchronization therapy (CRT) systems.
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.
- 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 to 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);
- 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.