At a Glance
- Tasks: Create and maintain technical documentation for innovative cancer care products.
- Company: Join Endomag, a Hologic company, redefining cancer treatment.
- Benefits: Collaborative culture, personal growth opportunities, and impactful work.
- Other info: Dynamic team environment with a focus on continuous improvement.
- Why this job: Make a real difference in cancer care while developing your skills.
- Qualifications: Background in engineering or science with technical documentation experience.
The predicted salary is between 35000 - 45000 € per year.
Role location: Cambridge, UK
Discover a career with real meaning. One that offers the opportunity to showcase your talents, achieve measurable success and gain immense satisfaction by shaping the future of cancer care.
At Endomag, a Hologic company, we’re redefining cancer treatment and empowering clinicians worldwide with innovative medical solutions. We’re now looking for a Technical Documentation Specialist to join our dynamic team in Cambridge. As a Technical Documentation Specialist, you will play a pivotal role in ensuring the accuracy, consistency and compliance of technical documentation for our products. You will collaborate with multi-disciplinary engineers, clinical trial managers, regulatory affairs specialists and quality assurance experts to create and maintain audit-ready documentation. Your efforts will directly support to deliver innovative, high-quality medical technologies that transform cancer care and improve patient outcomes worldwide.
KEY RESPONSIBILITIES
- Oversee the creation and maintenance of technical documentation for Endomag’s products, including technical files and design history files, user needs, design inputs, design outputs, verification and validation testing plans and reports, engineering drawings and manufacturing specifications.
- Lead Cross-Functional Collaboration: act as the primary liaison between R&D, Regulatory Affairs, Clinical Affairs, Product Engineering and Quality Assurance, ensuring seamless integration of their inputs into the technical documentation.
- Champion Good Documentation Practices: adopt a meticulous approach to creating and editing content, driving efforts to improve documentation practices and ensure consistency and audit readiness.
- Support Regulatory Compliance: review technical documents to ensure compliance with Endomag’s Quality Management System, FDA, MDR regulations, and applicable international standards (e.g., ISO 13485, ISO 14971).
- Participate in Regulatory Submissions and Audits: facilitate reviews by internal and external auditors, interact with regulatory agencies as needed, and lead efforts to implement Corrective and Preventive Actions (CAPAs).
KNOWLEDGE, SKILLS & EXPERIENCE
- Educational background in engineering or a scientific field.
- Experience in creating and editing technical reports and documentation.
- Exceptional attention to detail and high levels of accuracy.
- Demonstrated ability to take ownership of initiatives, deliver results and drive continuous improvement.
- Excellent content creation and editing skills.
- Excellent written and verbal communication skills, with the ability to communicate effectively with cross-functional teams and regulatory agencies.
- Good organizational and time management skills to handle conflicting priorities and meet tight deadlines.
- Experience in design assurance, quality or technical documentation roles in the medical device industry or other regulated industries, e.g. automotive, aerospace is highly desirable.
Ready to Make an Impact? If you have the right skills and experience and want to join our team, apply today. We can’t wait to hear from you!
Innovate with Purpose: Work at the forefront of life-changing medical technology.
Collaborative Culture: Join a friendly, supportive team where your contributions matter.
Personal Growth: Expand your skills in a fast-growing, global company.
Technical Documentation Specialist in Duloe employer: Hologic
At Endomag, a Hologic company, we pride ourselves on being an exceptional employer that fosters a collaborative culture and prioritises personal growth. Located in the vibrant city of Cambridge, our team is dedicated to redefining cancer care through innovative medical solutions, offering employees the chance to make a meaningful impact while enjoying a supportive work environment and opportunities for professional development.
StudySmarter Expert Advice🤫
We think this is how you could land Technical Documentation Specialist in Duloe
✨Tip Number 1
Network like a pro! Reach out to folks in the medical device industry, especially those who work at Endomag or similar companies. A friendly chat can open doors and give you insights that might just land you an interview.
✨Tip Number 2
Showcase your skills! Create a portfolio of your technical documentation work. Whether it’s reports, user manuals, or design files, having tangible examples will make you stand out when you apply through our website.
✨Tip Number 3
Prepare for the interview by brushing up on regulatory standards like ISO 13485 and FDA guidelines. Being able to discuss these confidently will show that you’re not just a fit for the role, but also passionate about compliance.
✨Tip Number 4
Follow up after your application! A quick email thanking the hiring team for their time can keep you fresh in their minds. Plus, it shows your enthusiasm for the Technical Documentation Specialist role!
We think you need these skills to ace Technical Documentation Specialist in Duloe
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Technical Documentation Specialist role. Highlight relevant experience in creating and editing technical documentation, and don’t forget to showcase your attention to detail and organisational skills!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you’re passionate about cancer care and how your skills align with our mission at Endomag. Be sure to mention any experience with regulatory compliance and cross-functional collaboration.
Showcase Your Communication Skills:As a Technical Documentation Specialist, communication is key. In your application, demonstrate your ability to communicate effectively with diverse teams. Share examples of how you've successfully collaborated with engineers or regulatory affairs specialists in the past.
Apply Through Our Website:We encourage you to apply through our website for the best chance of getting noticed. It’s super easy, and you’ll be able to submit all your documents in one go. Plus, we love seeing applications come directly from our site!
How to prepare for a job interview at Hologic
✨Know Your Documentation Inside Out
Before the interview, make sure you’re familiar with the types of technical documentation relevant to the role. Brush up on your knowledge of design history files, verification and validation testing plans, and regulatory compliance standards like ISO 13485. This will show that you’re not just interested in the role but also understand the intricacies involved.
✨Showcase Your Collaboration Skills
Since this role involves working closely with various teams, be prepared to discuss your experience in cross-functional collaboration. Think of specific examples where you’ve successfully liaised between different departments, such as R&D and Quality Assurance, to create comprehensive documentation. Highlighting these experiences will demonstrate your ability to integrate diverse inputs effectively.
✨Emphasise Attention to Detail
Given the importance of accuracy in technical documentation, be ready to share instances where your attention to detail made a significant impact. Whether it’s catching an error in a report or improving documentation practices, showcasing your meticulous nature will resonate well with the interviewers.
✨Prepare for Regulatory Questions
Expect questions about regulatory compliance and how you’ve navigated audits or submissions in the past. Familiarise yourself with FDA and MDR regulations, and be ready to discuss how you’ve ensured compliance in your previous roles. This will highlight your readiness to support Endomag’s commitment to quality and safety.
