Job Overview
The Senior Quality Systems Engineer is a pivotal role in the establishment, implementation, and maintenance of our company's quality management system.
This is a unique opportunity to work within a supportive team in a state-of-the-art facility.
Key Responsibilities:
* Ensure compliance with Medical Device Directive 93/42/EEC, Medical Device Regulation 2017/745, FDA Quality System Regulations 21 CFR § 820 & 803, ISO 13485, and ISO 14971.
* Maintain and continuously improve quality management systems.
* Coordinate CAPA, Complaints & Temporary Authorization (Deviations) processes.
* Review and approve Non-conformance, CAPA, and Complaint investigation reports.
* Manage audit schedules, coordinating internal and external audits as necessary.
* Prepare for and manage audits by regulatory bodies.
* Collect and analyze quality systems data to generate timely monthly reports, etc.
Requirements:
* Education to a Diploma Level in an Engineering, Science, or Quality Assurance discipline.
* Training/Qualification in Quality Systems, Complaints, and CAPA is highly desirable.
* A minimum of five years' experience in the medical device industry.
* Familiarity with ISO 13485, ISO 14971, Medical Device Regulation 2017/745, and FDA QSRs is required.
* Experience in managing quality systems activities, particularly Complaints and CAPA, is desirable.