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 Helpston 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. With opportunities for skill expansion and a commitment to excellence, joining us as a Technical Documentation Specialist means becoming part of a mission-driven organisation that values your contributions and encourages continuous improvement.
StudySmarter Expert Advice🤫
We think this is how you could land Technical Documentation Specialist in Helpston
✨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 applying! A quick email expressing your enthusiasm for the Technical Documentation Specialist role can keep you on their radar. It shows initiative and keeps the conversation going.
We think you need these skills to ace Technical Documentation Specialist in Helpston
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. Mention any specific examples where your attention to detail made a difference in your previous roles, especially in compliance or quality assurance.
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 us you’re keen on joining our innovative team!
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 examples of how you've successfully collaborated in the past. Think about specific projects where you acted as a liaison between different departments and how you ensured everyone was on the same page. This will highlight your ability to work in a cross-functional environment.
✨Demonstrate 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. You might want to mention any processes you’ve implemented to improve documentation practices or how you’ve handled audits in the past. This will reinforce your fit for the meticulous nature of the role.
✨Prepare for Regulatory Questions
Expect questions related to regulatory compliance and quality management systems. Familiarise yourself with FDA and MDR regulations, and be ready to discuss how you’ve navigated these in previous roles. Showing that you can handle regulatory submissions and audits will set you apart from other candidates.
