CORCYM is a global medical device company.
It has acquired a complete portfolio of surgical solutions with a heritage spanning more than 50 years.
CORCYM employs approximately 850 people in over 100 countries, ensuring a strong presence to continuously support patients, healthcare professionals and healthcare systems worldwide.
We are seeking a talented, young biomedical engineer to join our Customer Quality Department on an internship contract with the potential for permanent employment.
The ideal candidate will be passionate, curious, quick to learn, and have a strong aptitude for interpersonal relationships, client interactions, and teamwork.
They should be capable of managing their work in an organized and autonomous manner, be deadline-oriented, and offer the necessary flexibility when required.
This role involves developing strong technical and clinical expertise in the field of cardiac surgery, with a particular emphasis on heart valves and valve repair devices, as well as gaining a comprehensive understanding of the regulatory processes essential for the commercialization of a medical device.
As this is a global role, fluency in both written and spoken English is essential.
Join us today and take life to heart!
Job Description POSITION SUMMARY Responsible for conducting investigations to determine the root cause of complaints received, including the physical analysis and testing of returned devices when available.
Coordinates the activities of relevant departments involved in the investigation (e.g., Product Innovation, Quality Engineering, external labs) as needed.
Acts as a front-end function for both collecting the information needed to support the investigation and delivering investigation results, directly liaising with Corcym field force and healthcare professionals.
Prepares reports and maintains documentation in accordance with implemented quality programs and policies.
Collaborates in the preparation and submission of medical incident reports to regulatory authorities related to vigilance cases.
Assists in the activities for the Correction and Removal process when required.
Stays abreast of any possible changes in the regulatory environment globally, to ensure compliance with medical device regulations.
ESSENTIAL JOB FUNCTIONS - Evaluate, investigate, track and complete complaint investigations
- Collaborate with Product Innovation, Sales and Marketing, Clinical, and other appropriate departments for adequate initial evaluation and investigation of complaints.
- Perform all requested tasks to support the investigation of complaints, including follow-up activities with customers and/or Corcym sales representatives
- Conduct and coordinate the physical investigation of devices returned for complaints
- Ensure accurate documentation of evaluation and investigation results with the assigned complaint records.
- Participate and collaborate objectively with productive conclusions in the complaint handling meetings.
- Collaborate in the preparation and submission of medical incident reports to Regulatory Authorities related to vigilance cases
- Assist in the activities for Correction and Removal process when required.
- Release signed technical documents (e.g.
MRI declarations, Investigation Reports) when requested.
- Monitors guidelines, collect process and quality data to determine trends and identify potential risks
- Support the Regulatory Department with the production of post-market surveillance reports.
- Supports audits to assure adherence to in-house and/or external specifications and standards, such ISO 9001/13485 and applicable medical device regulations.
- Collaborate in the review and update of Customer Quality Department processes and procedures, based on the changing needs of the Company and of the Regulatory environment.
- Conduct training sessions on complaint and customer feedback handling for Corcym employees and sales representatives.
KNOWLEDGE, SKILLS AND ABILITIES REQUIRED - Robust technical knowledge
- Ability to understand clinical data and statistical analyses
- Must be able to communicate fluently and clearly in English, both verbally and in writing
- Advanced knowledge of Microsoft Office Suite: Word, Excel, PowerPoint, Outlook.
Ability to perform spreadsheet calculations and produce graphs, reports, and documents.
- Ability to effectively interact and communicate with all levels of personnel in the Company.
- Demonstrate initiative, organized work habits, attention to detail, and capable of performing assignments with limited supervision.
- Complete multiple tasks in a timely and thorough manner, with maximum attention to detail.
EDUCATION Bachelor's degree in biomedical engineering
EXPERIENCE None required as the collaboration will start with an Internship experience.
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