National AI Awards 2025Discover AI's trailblazers! Join us to celebrate innovation and nominate industry leaders.

Nominate & Attend

Senior QA Design Officer

JR United Kingdom
Cambridge
3 days ago
Create job alert

Social network you want to login/join with:
CAPU Search is proud to be working with our long-term partner Endomag, now part of the Hologic, to identify a Senior QA Design Officer (Micro) to support innovation and growth across their product portfolio.
Over the last decade, we’ve seen Endomag evolve from an academic research project into a global MedTech company. Their mission remains the same: to make breast cancer care more precise and less invasive.
Now used in over 1,350 hospitals across 45+ countries, and having helped over 500,000 women access better treatment, Endomag is entering an exciting new chapter following their acquisition by Hologic in 2024.
This is a great opportunity to join a purpose-driven team, play a key role in design control and product introduction, and help shape the future of QA within a business that’s still growing fast.
The purpose of the role:
The main function of this role will involve interacting with both Product Engineering and R&D, in introducing new products (the majority being sterile) and controlling design improvements to the existing portfolio to ensure the ongoing design review and release process is maintained as projects progress.
This role will also support the release process, of sub contract production devices, to ensure continued compliance of our existing portfolio. Which include class IIa, IIb and Class III sterile devices.
Other functions within this role will involve support functions, to the Quality and Regulatory team, Helping to maintain the companies Iso13485 quality system, liaising with various departments in a busy and dynamic environment
Key Responsibilities and duties:
Implement and manage Design Control in regards to global Quality standards regulations and other requirements.
Participate or manage the QA design meetings, reviews and release process ensuring that it maintains the requirement of ISO 13485;2016, regulatory requirements and our quality system.
Assist with preparation of quality documentation as required for other worldwide territories eg FDA, TGA etc.
Participate during audits by Notified Body or other organisations as required.
Author/preparation of quality documentation as required for product introduction and improvement, including material and sterilisation controls ISO 10993, ISO11135, ISO11737.
Documentation control to ensure implementation of changes to procedures, technical files within the QMS and technical files as standards evolve.
Maintaining quality procedures across supply chain partners and manufacturers to ensure compliance to standards.
Support the team to ensure quality audit actions are completed in a timely manner
Ensure activities meet with and integrate with organisational requirements for health and safety, legal stipulations, environmental policies and general duty of care.
INDIVIDUAL SPECIFICATION
Qualifications
Experience in Design and change control under ISO13485:2016 requirements is the major consideration
Design and Development process knowledge and experience
Previous experience working with eQMS systems
Degree or equivalent in Microbiology /Molecular Biology or closely related field
Experience and Knowledge
Minimum 5 years’ experience in ISO quality systems, ideally, sterile medical devices. or pharmaceuticals.
Experience in Design and change control under ISO13485:2016 requirements is the major consideration
Understanding and worked on risk assessments to ISO 14971:2019
Design and Development process knowledge/experience around material and sterilisation compatibility processes. ISO 10993, ISO11135, ISO11737
Evidence of experience working in a busy and demanding environment within a team and individually
Good IT skills (MS Office) are required
Experience eQMS systems is preferred
Experience with validation.
Abilities and Skills
Self-starter with strong motivational skills
Good written skills, demonstrated in a range of contexts
Evidence of effective communication and inter-personal skills
Evidence of ability to work with critical attention to detail and high levels of accuracy
Proven organisational and time management skills to effectively handle conflicting priorities and ensure tight deadlines are met
Experience in working for a small, dynamic organisation
Other
Willingness to occasionally travel in UK and ROW

#J-18808-Ljbffr

Related Jobs

View all jobs

Senior QA Design Officer

Senior QA Design Officer

Senior QA Design Officer

Senior QA Engineer (we have office locations in Cambridge, Leeds & London)

Senior / Principal Electrical design engineer MEP Building Services

Senior / Principal Electrical design engineer MEP Building Services

National AI Awards 2025

Subscribe to Future Tech Insights for the latest jobs & insights, direct to your inbox.

By subscribing, you agree to our privacy policy and terms of service.

Industry Insights

Discover insightful articles, industry insights, expert tips, and curated resources.

How to Present Biotech Concepts to Non-Scientists: A Public Speaking Guide for Job Seekers

In today’s biotechnology job market, your ability to explain complex science clearly is just as important as your lab skills. Whether you're applying for a research role, pitching to investors, or collaborating with marketing teams, you'll often need to present technical information to people without a scientific background. This blog explores how biotechnology job seekers can develop and deliver compelling presentations that make sense to non-scientists. From structuring your content to designing effective slides and using storytelling to bring data to life, these techniques will help you stand out in interviews and on the job.

Biotech Jobs Employer Hotlist 2025: 50 UK Companies Actively Hiring Right Now 

Bookmark this guide – we refresh it every quarter so you always know who’s really expanding their life‑science teams. The UK biotechnology scene is on a tear in 2025. Venture & follow‑on funding hit £3.5 billion last year, up 94 % on 2023, and Q1 2025 alone brought in another £924 million of equity for scaling therapeutics, diagnostics & deep‑tech platforms  bioindustry.org. Meanwhile, Westminster’s new industrial strategy pledges a record £86 billion for science & tech, with life sciences top of the eight “high‑growth” priority sectors . The consequence? Hiring is white‑hot. From big‑pharma giants to gene‑editing start‑ups, employers need research scientists, QC analysts, bioprocess engineers, bioinformaticians, regulatory specialists & commercial leads – right now. Below you’ll find 50 organisations that have posted UK vacancies or announced head‑count growth during the past eight weeks. They’re grouped into five bite‑size categories so you can jump straight to the type of employer – & mission – that excites you. For every entry you’ll see: Main UK hub Example recent vacancy Why it’s worth your time (tech, culture, impact) Use the internal search on BiotechnologyJobs.co.uk to pull up live roles, or set a free alert so fresh openings land in your inbox.

Return-to-Work Pathways: Relaunch Your Biotechnology Career with Returnships, Flexible & Hybrid Roles

Returning to work after a career break can feel like stepping into a new frontier—especially in a fast-evolving sector such as biotechnology. Whether you’ve paused your professional journey for parenting, caring responsibilities or another life chapter, the UK’s biotech industry now offers a variety of return-to-work pathways designed to help you transition back smoothly. From formal returnships and part-time contracts to hybrid and fully flexible roles, these programmes acknowledge the value of your transferable skills and life experience. In this guide tailored for parents and carers, you’ll discover how to: Grasp the current demand for biotech talent in the UK Translate your organisational, communication and resilience skills into the laboratory and beyond Tackle common re-entry challenges with practical solutions Refresh your scientific and technical knowledge through targeted learning Access returnship and re-entry programmes specifically in biotech Find roles that fit around family commitments—be they flexible, hybrid or full-time Balance work with caring duties Navigate applications, interviews and networking in the biotech world Learn from inspiring returner success stories Get quick answers in our FAQ section Whether you’re keen to step back into a research lab, quality control, regulatory affairs or bioinformatics team, this article will map out the steps and resources you need to reignite your biotechnology career.