Job Title: Senior Quality Systems Engineer
Job Description:
The successful candidate will play a key role in the implementation and maintenance of our quality management system. This is an exciting opportunity to work as part of a supportive, collaborative team in our state-of-the-art facility.
Key Responsibilities:
* Ensure compliance with relevant regulatory requirements, including Medical Device Directive 93/42/EEC, Medical Device Regulation 2017/745, FDA Quality System Regulations 21 CFR 820 & 803, ISO 13485, and ISO 14971.
* Maintenance and continuous improvement of the quality management systems.
* Act as Coordinator for CAPA, Complaints & Temporary Authorization (Deviations) processes to support owners in meeting required timelines.
* Review and approval of Non-conformance, CAPA, and Complaint investigation reports.
* Act as Coordinator for the Audit Management Process. Manage the annual audit schedule and coordinate internal and external audits as required.
* Track audit actions from initiation to closure.
* Coordinate activities in the preparation and management of audits by regulatory bodies.
* Manage Quality Systems data collection and analysis to facilitate timely generation of Monthly Reports, Management Review data etc.
* Prepare and present data to management on quality system performance, including Monthly Quality Reports.
* Generate Quality Systems data as required for Post Market Surveillance purposes.
Required Skills and Qualifications:
Educated at a minimum 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 relevant experience in the medical device industry. Familiarity of ISO13485, ISO14971, Medical Device Regulation 2017/745 and FDA QSRs is required.
Experience in management of Quality Systems activities, in particular Complaints and CAPA is desirable.
Benefits:
Bonus, pension, healthcare, hybrid working.