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- Tasks: Lead quality assurance processes and ensure compliance with medical device regulations.
- Company: Join Southern Scientific, a leader in radiation detection equipment across various sectors.
- Benefits: Enjoy a collaborative culture and the chance to work with cutting-edge technology.
- Why this job: Be part of a passionate team dedicated to quality and innovation in medical devices.
- Qualifications: Experience in medical device QA and knowledge of ISO standards are essential.
- Other info: Opportunity for travel and collaboration with international teams.
The predicted salary is between 36000 - 60000 £ per year.
2 days ago Be among the first 25 applicants
Direct message the job poster from Southern Scientific Ltd
Group Human Resources Manager for the LabLogic Group
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
- 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
- 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.
- Hosting a regulatory external audit.
- Risk Management (working to ISO 14971 and FEMA).
- Managing ISO 14001.
- Understanding of Data Protection.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Quality Assurance
Industries
Medical Equipment Manufacturing
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Quality Assurance Manager employer: Southern Scientific Ltd
Contact Detail:
Southern Scientific Ltd Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Assurance Manager
✨Tip Number 1
Familiarize yourself with the specific regulatory frameworks mentioned in the job description, such as EU MDR and FDA regulations. Understanding these will not only help you in interviews but also demonstrate your commitment to the role.
✨Tip Number 2
Network with professionals in the medical device industry, especially those who have experience in quality assurance roles. This can provide you with insights into the company culture at Southern Scientific and may even lead to referrals.
✨Tip Number 3
Prepare to discuss your previous experiences with ISO 13485 and ISO 9001 during the interview. Be ready to share specific examples of how you've implemented these standards in past roles.
✨Tip Number 4
Showcase your ability to manage change control and document control processes. Highlight any relevant experiences where you successfully navigated quality issues or led internal audits, as this aligns closely with the responsibilities of the QA Manager role.
We think you need these skills to ace Quality Assurance Manager
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your previous experience in quality assurance, especially within the medical device sector. Emphasize your knowledge of ISO 13485 and ISO 9001, as well as any relevant regulatory compliance experience.
Craft a Compelling Cover Letter: In your cover letter, express your passion for quality assurance and how it aligns with Southern Scientific's mission. Mention specific experiences that demonstrate your ability to manage QA processes and your understanding of regulatory requirements.
Showcase Communication Skills: Since excellent verbal and written communication skills are essential for this role, provide examples in your application of how you've effectively communicated quality objectives and regulatory compliance across different levels of an organization.
Highlight Continuous Improvement Initiatives: Discuss any initiatives you have led or participated in that focused on continuous improvement within a quality management system. This will show your proactive approach to promoting a culture of quality, which is crucial for the role.
How to prepare for a job interview at Southern Scientific Ltd
✨Showcase Your Regulatory Knowledge
Make sure to highlight your experience with medical device regulations such as EU MDR, MDSAP, and FDA during the interview. Be prepared to discuss specific examples of how you've implemented these regulations in previous roles.
✨Demonstrate Attention to Detail
Quality Assurance is all about precision. Bring examples of how your attention to detail has positively impacted quality processes in your past positions. This could include successful audits or CAPA investigations.
✨Communicate Effectively
Since the role requires liaising with various levels of staff, practice articulating your thoughts clearly and concisely. Prepare to discuss how you have previously communicated quality objectives and regulatory compliance to diverse teams.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving skills in quality-related incidents. Think of scenarios where you had to manage non-conformances or conduct internal audits, and be ready to explain your approach and outcomes.
