Find a job 
Featured Companies 
Featured Universities 
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, knowledge of ISO standards, and strong communication skills required.
- Other info: Based in Henfield, West Sussex, with travel to the Sheffield office as needed.
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.
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.
- 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: ZipRecruiter
Contact Detail:
ZipRecruiter 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 and ISO 9001. Understanding these frameworks will not only help you in interviews but also demonstrate your commitment to quality assurance in the medical device sector.
✨Tip Number 2
Network with professionals in the quality assurance field, especially those who have experience in medical devices. Engaging with industry groups or attending relevant conferences can provide insights and connections that may give you an edge in the application process.
✨Tip Number 3
Prepare to discuss your previous experiences with CAPA and internal/external audits during the interview. Be ready to share specific examples of how you've successfully managed quality issues and improved processes in past roles.
✨Tip Number 4
Showcase your ability to communicate effectively across all levels of an organisation. Think of examples where you've successfully promoted a culture of quality or trained others on QA procedures, as this aligns closely with the responsibilities of the 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 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: In your cover letter, express your passion for quality assurance and how it aligns with Southern Scientific's mission. Mention specific examples of how you've successfully managed QA processes or led teams in previous roles.
Showcase Your Communication Skills: Since excellent verbal and written communication skills are essential for this role, ensure that your application is clear, concise, and free of errors. Use professional language and structure your documents logically.
Highlight Continuous Improvement Initiatives: Discuss any initiatives you have led or contributed to that focused on continuous improvement in quality management systems. This will demonstrate your proactive approach and commitment to enhancing quality culture within an organisation.
How to prepare for a job interview at ZipRecruiter
✨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 effectively managed quality issues and the outcomes of those situations.
✨Emphasise Communication Skills
Since the role involves liaising with various levels of staff, be prepared to discuss how you communicate quality objectives and promote a culture of quality within an organisation. Share examples of successful training sessions or presentations you've conducted.
