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- Tasks: Manage risk documentation for innovative healthcare products and support quality assurance.
- Company: Join Randox, a leading global diagnostics company making a real impact on healthcare.
- Benefits: Enjoy flexible working hours and a supportive team environment.
- Why this job: Be part of a mission-driven company improving health worldwide with cutting-edge technology.
- Qualifications: Degree level education or relevant experience; strong IT skills required.
- Other info: Opportunity to work in a dynamic environment with potential for career growth.
The predicted salary is between 30000 - 42000 £ per year.
Device Documentation Specialist (Job Ref: 25N/DVDD)
Randox Laboratories continues to develop disruptive innovations within the Diagnostics and Healthcare sector globally. We are proud to have been named the Number 1 company in Northern Ireland, for the second consecutive year in the Belfast Telegraph Top 100 Companies 2024. Our staff are at the heart of everything we do and achieve. We have an exciting career opportunity for a Device Documentation Specialist within our Quality Assurance team.
Location: Randox Science Park, 30 Randalstown Rd, Antrim BT41 4FL.
Contract Offered: Full-time, Permanent.
Working Hours / Shifts: 40 hours per week. There are options available to work 10 hour days from Monday to Thursday or 9 hour days Monday to Thursday and 4 hours on a Friday.
What does this role involve?
This role is responsible for the risk management files for all Randox products. Some of the main duties include:
- Periodic review, revision and reissuing of Risk Management documentation for Randox products.
- Review, revision and reissuing of Risk Management documentation for Randox products following design change, purchasing change,new hazards identified following post market surveillance, CAPA completion and vigilance reports.
- Attendance and contribution at technical support, design change, Non -conforming Product/ Process and Post market surveillance meetings.
- Periodic review and update of Safety data sheets for Randox products forecast related enquiries and issues.
- Assisting in external & internal quality system audits.
- Provide support when required and ensure that customers, distributor and OEM partners are serviced at the highest level of satisfaction through quality service and quick responses.
- The promotion of quality awareness throughout the company.
Who can apply?
Essential criteria:
- Educated to Degree level or possess relevant experience in a similar role.
- Strong IT skills including Word, Excel, PowerPoint, Microsoft Outlook.
- Experience with interpretation of technical information and performance data.
- Previous experience within an office environment.
Desirable:
- Life Science degree.
- Previous experience in a similar role.
- Knowledge or experience in Quality Systems
This advert may be open for as long as 30 days although we may close the advert early if we receive sufficient applicants to fill the roles.
About Randox:
An international company operating in over 145 countries that continues to have unparalleled growth, Randox Laboratories was at the centre of the UKs National COVID Testing Programme throughout the pandemic. In early 2020 Randox recognised the threat from COVID-19 and, based on over 40 years of diagnostic experience, quickly developed a test to accurately identify the virus. Testing at scale commenced within weeks to support the UKs National Testing Programme and private clients alike.
Additionally, as a world leader in diagnostics for clinical healthcare, toxicology and food security, our expertise and product portfolio have assisted laboratories across the world in improving health and saving lives. Our global success is a result of our pioneering products and the commitment & skill of our workforce, which continue to grow exponentially.
Central to the Randox ethos is our drive and determination to improve healthcare worldwide and every one of our talented staff play a role in this. In order to serve our growing international markets, we require high calibre applicants with scientific, engineering, software, and broader business skills including sales, marketing, logistics, finance and many more. Join the Randox team and play your part in improving the health of millions.
Randox Laboratories Limited is an Equal Opportunities Employer.
Device Documentation Specialist employer: Randox Laboratories
Contact Detail:
Randox Laboratories Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Device Documentation Specialist
✨Tip Number 1
Familiarise yourself with the specific risk management processes and documentation standards used in the diagnostics and healthcare sector. Understanding these will help you speak confidently about your knowledge during interviews.
✨Tip Number 2
Network with professionals in the quality assurance field, especially those who work in medical devices or diagnostics. Attend relevant industry events or join online forums to gain insights and potentially get referrals.
✨Tip Number 3
Prepare to discuss your experience with technical documentation and quality systems in detail. Be ready to provide examples of how you've contributed to quality assurance in previous roles, as this will demonstrate your suitability for the position.
✨Tip Number 4
Research Randox Laboratories thoroughly, including their products and recent innovations. Showing that you understand their mission and values can set you apart from other candidates during the interview process.
We think you need these skills to ace Device Documentation Specialist
Some tips for your application 🫡
Understand the Role: Carefully read the job description for the Device Documentation Specialist position. Make sure you understand the key responsibilities and required skills, as this will help you tailor your application.
Highlight Relevant Experience: In your CV and cover letter, emphasise any relevant experience you have in risk management documentation, quality systems, or similar roles. Use specific examples to demonstrate your skills and achievements.
Showcase IT Proficiency: Since strong IT skills are essential for this role, make sure to mention your proficiency in Word, Excel, PowerPoint, and Outlook. Provide examples of how you've used these tools effectively in previous positions.
Craft a Compelling Cover Letter: Write a personalised cover letter that explains why you are interested in the Device Documentation Specialist role at Randox Laboratories. Connect your background and skills to the company's mission and values, showing how you can contribute to their success.
How to prepare for a job interview at Randox Laboratories
✨Understand the Role
Make sure you thoroughly understand the responsibilities of a Device Documentation Specialist. Familiarise yourself with risk management documentation and quality assurance processes, as these will be key topics during your interview.
✨Showcase Your IT Skills
Since strong IT skills are essential for this role, be prepared to discuss your proficiency in Word, Excel, PowerPoint, and Outlook. Consider bringing examples of how you've used these tools effectively in previous roles.
✨Prepare for Technical Questions
Expect questions related to interpreting technical information and performance data. Brush up on relevant concepts and be ready to demonstrate your analytical skills and problem-solving abilities.
✨Emphasise Quality Awareness
Randox values quality awareness throughout the company. Be prepared to discuss how you have promoted quality in your previous roles and how you can contribute to maintaining high standards at Randox.
