PMS Specialist
Medartis develops, manufactures and distributes titanium screws and plates, surgical instruments and system solutions for fracture fixation. We place the highest priority on maintaining stringent quality standards, continuous further development and innovation as well as comprehensive service provision for physicians, staff and patients.
The PMS Specialist provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with internal and external standards and guidelines. This position manages activities related to Post Market Surveillance while maintaining and improving any associated compliance related process'.
The PMS Specialist provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with internal and external standards and guidelines. This position manages activities related to Post Market Surveillance while maintaining and improving any associated compliance related process'.
Your responsibilities
- Manage the post market surveillance (PMS) system.
- Ensure all PMS documentation and records are properly completed and maintained in the designated document control system per applicable company procedures.
- Initiate, coordinate and process customer complaints per applicable company procedures including communicating with customers regarding complaint information.
- Asses risk and reportability of customer complaints per applicable regulatory requirements.
- Complete and submit documentation, in the required timeframe, for reportable events per applicable regulatory requirements.
- Ensure complaints are investigated, closed and documented per applicable company procedures.
- Initiate, coordinate and process health hazard evaluations (HHE’s) per applicable company procedures.
- Ensure HHE’s are investigated, closed and documented per applicable company procedures.
- Initiate, coordinate and process field safety corrective actions (FSCA) per applicable company procedures.
- Ensure FSCA’s are closed and documented per applicable company procedures.
- Gather, maintain and provide PMS data and metrics, as required, for Quality Management System (QMS) monitoring and Quality Management Review activities.
- Participate in QMS process’, including but not limited to, audits, corrective and preventative action (CAPA) investigations, and document control.
- Prepare and update Quality documents such as SOPs, Work Instructions and Forms.
- Review and approve records and documents to ensure conformance with regulations and Medartis procedures.
Your qualifications
- Bachelor of Science in Engineering or related field, or equivalent combination of experience and training.
- Previous experience in a regulated industry is preferred.
- Proficient in the use of Microsoft Word, PowerPoint and Excel.
- Knowledge of basic engineering principals.
What we offer
This is an integral, responsible and diversified role with a focus on quality and service provision in a rapidly growing, international company. We look forward to receiving your complete application.
For further information please visit our Website www.medartis.com.
We look forward to receiving your complete online application.
We look forward to receiving your complete online application.
