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 meaningful work.
- Other info: Dynamic team environment with a focus on continuous improvement.
- Why this job: Make a real impact in life-changing medical technology.
- 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).
- 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 Chalton 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 Chalton
✨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
Prepare for the interview by brushing up on your technical documentation skills. Be ready to discuss how you've ensured compliance and accuracy in past roles. We want to see your passion for detail and quality!
✨Tip Number 3
Showcase your collaborative spirit! Highlight experiences where you’ve worked with cross-functional teams. We love seeing candidates who can bridge gaps between engineering, regulatory affairs, and quality assurance.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, it shows us you’re genuinely interested in being part of our mission to transform cancer care.
We think you need these skills to ace Technical Documentation Specialist in Chalton
Some tips for your application 🫡
Tailor Your Application:Make sure to customise your CV and cover letter for the Technical Documentation Specialist role. Highlight your experience in creating technical documentation and your attention to detail, as these are key for us at Endomag.
Showcase Your Collaboration Skills:Since this role involves working with various teams, don’t forget to mention any past experiences where you’ve successfully collaborated with cross-functional teams. We love seeing how you can bring people together!
Be Meticulous:Attention to detail is crucial in technical documentation. When writing your application, ensure it’s free from errors and clearly structured. This will show us that you practice what you preach when it comes to good documentation practices.
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it’s super easy!
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, user needs, and regulatory compliance standards like ISO 13485. This will show that you’re not just interested in the job but also understand the nuances of the documentation process.
✨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 acted as a liaison between different departments, and how you ensured everyone’s input was integrated into the documentation. This will highlight your ability to work well in a team setting.
✨Demonstrate Attention to Detail
Attention to detail is crucial for a Technical Documentation Specialist. During the interview, share instances where your meticulous approach made a difference in your previous roles. You could mention how you improved documentation practices or caught errors that others missed, showcasing your commitment to quality.
✨Prepare for Regulatory Questions
Given the importance of regulatory compliance in this role, expect questions about your experience with FDA regulations and quality management systems. Brush up on key regulations and be ready to discuss how you’ve navigated audits or regulatory submissions in the past. This will demonstrate your readiness to support Endomag’s compliance efforts.
