Quality Assurance & Regulatory Affairs Specialist

At Medartis, we combine innovative solutions with skilled professionals to be the provider of choice in orthopaedics. Founded in 1997 and headquartered in Basel, Switzerland, the Medartis Group is one of the world’s leading manufacturers and providers of medical devices for the surgical fixation of bone fractures in the upper and lower extremities, as well as the craniomaxillofacial region. The company employs around 1,400 people across its 13 locations and sells its products in over 50 countries worldwide.

The Quality Assurance & Regulatory Affairs Specialist will provide oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with internal and external standards and guidelines. Manage activities related to Post Market Surveillance while maintaining and improving any associated compliance related processes.

Please note: This is an onsite position located in Warsaw, Indiana

Your responsibilities

Manage the post market surveillance 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.
Ensure complaints are investigated, closed and documented per applicable company procedures.
Complete and submit documentation to regulatory authorities, in the required timeframe, for reportable events per applicable regulatory requirements, ex. FDA MDRs
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 actions per applicable company procedures.
Ensure field actions are closed and documented per applicable company procedures.
Gather, maintain and provide PMS data and metrics, as required, for Quality Management System (QMS) monitoring.
Participate in QMS processes 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.
Follow FDA Quality Systems Regulation, ISO Standards and Standard Operating Procedures as established by Medartis policies, practices and procedures.
Maintain effective working relations, communications and feedback with all other departments and external partners.
Ensure that all record keeping, and documentation is completed in a timely manner according to established policies, practices and procedures.

Your qualifications

Good understanding of ISO 13485:2016
Good understanding of CFR Part 803 Medical Device Reporting
Good understanding of CFR Part 806 Medical Devices; Reports of Corrections and Removals
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.