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 Gold Hill 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 Gold Hill
✨Tip Number 1
Network like a pro! Reach out to folks in the industry, attend meetups or webinars, and connect with people on LinkedIn. You never know who might have the inside scoop on job openings or can refer you directly.
✨Tip Number 2
Prepare for interviews by researching the company and its products. Understand their mission and values, especially how they’re redefining cancer treatment. This will help you tailor your answers and show you’re genuinely interested.
✨Tip Number 3
Practice your communication skills! As a Technical Documentation Specialist, you’ll need to convey complex information clearly. Try mock interviews with friends or use online platforms to refine your verbal skills.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen. Plus, it shows you’re keen on joining our team at Endomag and making a real impact in cancer care.
We think you need these skills to ace Technical Documentation Specialist in Gold Hill
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 any relevant regulatory knowledge. We want to see how your skills align with our mission at Endomag!
Showcase Your Attention to Detail:In this role, accuracy is key! Use specific examples in your application that demonstrate your meticulous approach to documentation. We love candidates who can show us they take pride in their work and understand the importance of compliance.
Highlight Collaboration Skills:Since you'll be working with various teams, it's essential to showcase your ability to collaborate effectively. Share experiences where you've successfully liaised with different departments or stakeholders. We value teamwork and want to see how you can fit into our dynamic environment!
Apply Through Our Website:We encourage you to apply directly through our website for the best chance of getting noticed. It’s the easiest way for us to keep track of your application and ensure it reaches the right people. Don’t miss out on this opportunity to make an impact!
How to prepare for a job interview at Hologic
✨Know Your Stuff
Make sure you brush up on the technical aspects of documentation relevant to the medical device industry. Familiarise yourself with standards like ISO 13485 and ISO 14971, as well as the specific regulations that Endomag adheres to. This will show your potential employer that you're not just interested in the role, but that you understand the industry's requirements.
✨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 examples where you've successfully liaised between different departments, and how you ensured everyone’s input was integrated into the final documentation. This will highlight your ability to work in a team-oriented environment.
✨Attention to Detail is Key
During the interview, emphasise your meticulous approach to creating and editing documents. You might want to share specific instances where your attention to detail made a significant difference in a project. This will demonstrate that you take quality seriously, which is crucial for compliance in the medical field.
✨Prepare for Regulatory Questions
Expect questions about regulatory compliance and how you’ve handled audits or submissions in the past. Be ready to discuss any experiences you have with CAPAs or interacting with regulatory agencies. This will show that you’re not only knowledgeable but also experienced in navigating the complexities of regulatory environments.
