Job Description
\
As a Senior Quality Systems Engineer, you will play a pivotal role in the implementation and maintenance of our company's Quality Management System.
\
This is an exceptional opportunity to work as part of a supportive, collaborative team in our state-of-the-art facility. You will be responsible for ensuring that our Veryan Quality Systems are compliant with relevant regulations and directives, including the Medical Device Directive 93/42/EEC, Medical Device Directive 2007/47/EC, Medical Device Regulation 2017/745, FDA Quality System Regulations 21 CFR § 820 & 803, ISO 13485, ISO 14971 and Japanese Ministerial Ordinance # 169.
\
Key Responsibilities:
\
* Ensure compliance with regulatory requirements and directives
* Maintenance and continuous improvement of the quality management systems
* Act as Coordinator for CAPA, Complaints & Temporary Authorization (Deviations) processes
* Review & approval of Non-conformance, CAPA and Complaint investigation reports
* Act as Coordinator for the Audit Management Process
* Manage Quality Systems data collection and analysis
* Prepare and present data to management on quality system performance
* Generate Quality Systems data as required for Post Market Surveillance purposes
* Act as a primary contact for other departments providing quality oversight to ensure compliance and promote quality improvements
* Provide quality review on a range of documentation including procedures, specifications, investigations, and other Quality Management System documentation
\
Required Skills and Qualifications
\
We are seeking a highly skilled and experienced individual with a strong background in quality systems and regulatory compliance. The ideal candidate will have:
\
* 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' relevent 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
\
This is a fantastic opportunity to work in a state-of-the-art facility with a supportive and collaborative team. You will also benefit from:
\
* Hybrid working arrangement
* Top salary
* Bonus
* Pension
* Healthcare
],