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For Companies At a Glance
- 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 supportive work environment with opportunities for professional growth and development.
- Why this job: Be part of a passionate team dedicated to delivering high-quality products and exceptional service.
- Qualifications: Experience in medical device QA and knowledge of ISO standards are essential.
- Other info: This role is based in Henfield, West Sussex, with travel to Sheffield required.
The predicted salary is between 36000 - 60000 £ per year.
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.
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.
- Conducting periodic internal audits of company procedures.
- 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.
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
Familiarise yourself with the specific regulations and standards mentioned in the job description, such as ISO 13485, ISO 9001, EU MDR, and FDA requirements. This knowledge will not only help you during 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. Attend relevant conferences or webinars to connect with potential colleagues and learn more about the latest trends and challenges in QA.
✨Tip Number 3
Prepare to discuss your previous experiences in managing quality systems and handling audits. Be ready to share specific examples of how you've successfully implemented changes or improvements in QA processes in past roles.
✨Tip Number 4
Showcase your leadership skills by discussing how you've trained and motivated teams in previous positions. Highlight your ability to communicate complex regulatory requirements clearly to all levels of staff, as this is crucial for fostering a quality culture within the organisation.
We think you need these skills to ace Quality Assurance Manager
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in quality assurance, particularly within the medical device sector. Emphasise your knowledge of ISO 13485 and ISO 9001, as well as any experience with regulatory compliance such as EU MDR and FDA.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for quality assurance and your understanding of the company's mission. Mention specific experiences that demonstrate your ability to manage QA processes and your commitment to continuous improvement.
Highlight Key Achievements: In your application, include specific examples of how you've successfully managed non-conformances, conducted audits, or implemented quality systems. Use metrics where possible to quantify your impact on previous organisations.
Showcase Communication Skills: Since excellent communication is essential for this role, ensure your application reflects your ability to communicate effectively at all levels. Consider including examples of how you've trained staff or liaised with external auditors.
How to prepare for a job interview at Southern Scientific Ltd
✨Showcase Your Regulatory Knowledge
Make sure to highlight your understanding of medical device regulations such as EU MDR, MDSAP, and FDA requirements. Prepare specific examples from your past experience where you successfully navigated these regulations.
✨Demonstrate Attention to Detail
As a QA Manager, attention to detail is crucial. Be ready to discuss how you've implemented quality control measures in previous roles and how you ensure compliance with ISO standards.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving skills, especially regarding non-conformances and CAPA processes. Think of scenarios where you had to investigate quality issues and the steps you took to resolve them.
✨Emphasise Communication Skills
Since the role involves liaising with various teams, be prepared to discuss how you effectively communicate quality objectives across different levels of an organisation. Share examples of how you've trained staff on new QA procedures.
