Position type: Permanent shift
Location: Mildenhall, Suffolk
Salary: Negotiable/ to be determined
To provide support in implementing improvements and maintaining quality management systems across both medical and non- medical businesses. Writing and executing various types of documentation to achieve regulatory approvals for medical devices and non medical processes.
JEB Technologies are looking for a Senior Quality biased engineer that has the ability to understand the Medical Device Directives & Regulations and to implement the essential requirements for the development of medical devices whilst also being able to maintain/support and improve the non-medical side of the business. Applicants will be required to be disciplined, self-motivated and be able to work as both an individual and as part of a team. The individual must be confident and comfortable with generating documentation and producing written updates, so a working knowledge of Microsoft office programs will be essential.
For the right individual, JEB will provide on the job training and guidance which will allow the candidate to grow within the team and the company. The following items will form the basis of the job role.
– Providing QA support for the implementation and ongoing support of ISO 13485:2016, ISO9001: 2015, MDR and FDA
– To provide support with generating documentation relating to the manufacture of medical devices To provide support with generating documentation relating to the technical file and CE marking of medical products
– Generating documentation in line with ISO 13485 and other medical device regulatory requirements
– To function within all regulatory requirements and quality systems, particularly related to medical devices
– Dealing with suppliers, ensuring compliance with company policies, periodic auditing and completing Risk Management around the Approved Supplier List (ASL)
– Lead Auditor
– Auditing of vendors and subcontractors in line with ISO requirements
– Management and Control of Master Document List (MDL)
– Change Control (ECR), Corrective and Preventative (CAPA), Incoming Quality Reports (IQR), Out-Going Quality Audits, Supplier Corrective Action Request (SCAR), Root Cause Analysis (RCA)
– Strong problem solving skills and techniques
– Continuous improvement and a history of efficiency improvements
– To attend relevant training courses
– Methodical, logical and attention to detail
Qualifications and Experience
The above position is a critical role within the Quality group. The individual will work closely with colleagues, customers and suppliers to support the development of new medical devices and the maintenance of existing medical devices and to support existing non-medical products, equipment and processes. They may be required to undertake projects according to project management principles, and maintain compliance to regulatory and quality systems.
This position will require documentation generating qualities, skills and cross-functional teamwork. He or she will support implementation of projects of varying size and impact across a diverse set of medical devices. This will require knowledge of Regulatory and QA systems as well as good communication skills (verbal and written). This individual will be required to interact closely with other medical and non-medical team members, as well as cross-functional partners such as Marketing, Supply Chain, Engineering, and Sales.
– Minimum qualification for internal auditing to ISO9001:2015 and/or ISO13485:2016
– Minimum of 3 years Industry experience in the medical sector
– Strong project leadership skills (six sigma)
– Understanding of Cleanroom operation, environmental control and monitoring plan (EMP)
– Keeping training records and matrices up to date
– External Audit experience
– Control of Standards
Please send applications to [email protected]