Job Description
The Company
At Southern Scientific we’re passionate about our work, customers, people and our culture. We are a specialist supplier of radiation detection equipment for the Nuclear, Medical, Security, Defence, Industrial & Research sectors and are continually striving to be the very best at what we do through delivering the highest quality products and an exceptional service.
We are part of the LabLogic Group - a collection of companies sharing a common specialism in the detection and measurement of radioactivity. It consists of the UK-based companies LabLogic Systems Ltd, Southern Scientific, Knight Imaging and Care Wise alongside LabLogic Systems Inc (USA), LabLogic France and LabLogic Germany.
The Role
An exciting opportunity has arisen for a Quality Assurance (QA) Manager. Already operating a quality system to both ISO 13485 and ISO 9001, we are seeking a QA Manager with active involvement in medical device regulatory implementation (EU MDR, MDSAP, FDA and Canada SOR/98-202) to take us forward as we continue to grow. In this position (based at our Henfield, West Sussex facility) you will have support of other staff members involved with producing medical devices both at Southern Scientific and also within the LabLogic group. Reporting to the Managing Director at SSL, you will also be expected to work closely with the Group Quality Director based at Sheffield in order to harmonise group procedures where appropriate. Within this role, you will be responsible for managing and developing the Quality function at Southern Scientific and will be an essential member of the team, embodying the organisation’s quality culture.
Responsibilities
Your main responsibilities will be:
* Overseeing the company QA processes and procedures assuring alignment with the LabLogic Group where appropriate.
* Managing change control and document control.
* Managing non-conformances (CAPA), investigating quality issues, complaints, tracking preventative actions, and making sure that they are all addressed within the agreed time frame.
* Internal audits – conducting periodic internal audits of company procedures.
* External audits – liaising and hosting external audits, such as with Notified Bodies and customer vendor audits and subsequently ensuring any outcomes are acted upon swiftly and effectively.
* Supervising and delivering with relevant Managers training on new QA procedures as needed.
* Liaising with all members of staff at all levels: sharing quality aims, quality objectives, the importance of regulatory compliance, and driving continuous improvement to promote a culture of quality within the business.
* Making sure that the organisation is kept up to date with global changes to regulations affecting the products that are manufactured.
* Generating and presenting key departmental KPIs at management meetings.
* Approving and auditing suppliers.
The above list is not exhaustive and, as such, you may be required to undertake other duties as appropriate.
Requirements
Essential
* Previous experience within a medical device QA role that involved devices above a Class I device.
* Extensive knowledge of both ISO 13485 and ISO 9001.
* Understanding the demands of Regulatory compliance EU MDR, MDSAP,FDA and Canada SOR/98-202) on an SME organisation.
* Excellent attention to detail.
* Excellent verbal and written communication skills to be able to communicate, encourage and promote the QMS and regulatory requirements across all levels.
* Organised – able to set targets, goals, tasks, objectives and to deliver.
* Ability to quickly adjust to external pressures from quality related incidents.
* Willingness to travel to the Group Office located in Sheffield.
* Full UK driving licence.
Desirable
* Hosting a regulatory external audit.
* Risk Management (working to ISO 14971 and FEMA).
* Managing ISO 14001.
* Understanding of Data Protection.