Quality Management Systems Professional
5 days ago
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.
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