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).
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 Southill 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 Southill
✨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. Highlight your attention to detail and any projects where you collaborated with cross-functional teams. This will make you stand out when you apply through our website.
✨Tip Number 3
Prepare for interviews by brushing up on regulatory compliance knowledge. Familiarise yourself with ISO standards and FDA regulations relevant to technical documentation. Being well-versed will show you're serious about the role.
✨Tip Number 4
Follow up after interviews! A quick thank-you email can leave a lasting impression. It shows your enthusiasm for the role and keeps you fresh in their minds as they make their decision.
We think you need these skills to ace Technical Documentation Specialist in Southill
Some tips for your application 🫡
Tailor Your CV:Make sure your CV reflects the skills and experiences that match the Technical Documentation Specialist role. Highlight any relevant experience in creating technical documentation, especially in regulated industries like medical devices.
Craft a Compelling Cover Letter:Use your cover letter to tell us why you're passionate about cancer care and how your background makes you a great fit for our team. Be specific about your experience with cross-functional collaboration and good documentation practices.
Showcase Your Attention to Detail:In your application, demonstrate your meticulous approach to documentation. You might want to include examples of how you've ensured compliance and accuracy in past roles, as this is crucial for the position.
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 shows you’re keen on joining our innovative team!
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 products Endomag offers. This will show that you're not just interested in the role but also understand the industry's nuances.
✨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.
✨Attention to Detail is Key
Highlight your meticulous approach to documentation. Bring examples of past work where your attention to detail made a significant difference, whether it was catching an error or improving a process. This will demonstrate your commitment to quality and compliance.
✨Prepare for Regulatory Questions
Expect questions about regulatory compliance and audits. Brush up on your knowledge of FDA and MDR regulations, and be ready to discuss how you've navigated these in previous roles. Showing that you can handle regulatory scrutiny will set you apart from other candidates.
