Quality Engineer/Specialist

Binley Woods
6 days ago
Create job alert

Quality Engineer/Specialist
Location: Coventry, CV3 2RQ
Salary: Competitive (DOE)
Contract: Full-Time, Permanent
Why Join Us
Innovate in Healthcare – Be part of a forward-thinking medical devices company developing cutting-edge wound care solutions.
Make an Impact – Play a key role in ensuring regulatory compliance for life-changing medical products.
Global Reach – Work on regulatory strategies that impact markets across the UK, EU, USA, and beyond.
Perks & Benefits
• Competitive salary
• Contributory pension scheme
• Hybrid/Flexible working
• 33 days holiday (including bank holidays)
• Life cover & incapacity benefits
• Cash Back Medical Scheme
About Us
We’re not just a medical devices manufacturer – we’re innovators in advanced wound care solutions. Our high-quality, cost-effective products improve patient care and wellbeing worldwide.
Your Mission
As a Quality Engineer/Specialist, you will be responsible for supporting the management and continued effectiveness of Quality Management System within the business.
The Quality Engineer/Specialist will work closely with the Quality Manager to develop and deliver a range of proactive and responsive QMS and Supplier Quality Assurance (SQA) initiatives.
Key tasks and responsibilities:
• Lead supplier management including qualifications, performance evaluations, complaints, and corrective actions (SCARs),
• Lead the management of the business product and process change control programme,
• Lead the maintenance and management of the SFM training programme, ensuring training matrices and records are maintained,
• Lead the asset calibration programme,
• Support the management and co-ordination document control within the business via the use of the electronic document control systems, contributing to the drafting of documentation, managing the review, approval and distribution of documents including procedures, SOPs, WIs, and forms within the SFM QMS,
• Support the management and maintenance of the business integrated quality management system,
• Support the delivery and management of the business nonconformity programme,
• Support the delivery of the business’ audit programme including internal, customer, external, and leading the supplier audit programme,
• Deputise for the Quality Manager as required,
• Contribute to create and maintain a proactive leadership style and compliance culture throughout the company to achieve high standards of excellence, sharing best practice,
• Deliver any other duties as required by the line manager.
Compliance responsibilities:
• Adhere to and deliver the compliance scheme with the SFM regulatory, compliance and quality structure
Key Skills/ Abilities
• Regulatory, science or engineering degree or equivalent
• Knowledge of the Medical Device, Regulation EU 2017/745/EEC, USA 21 CFR 820, UKCA
• A demonstrable working knowledge and experience of applying ISO 13485, USA 21 CFR 820, EU MDR 2017/745, and Canada SOR 98.282 requirements within the Medical Devices or Pharmaceutical industries
• Dynamic and pragmatic team member and flexibility to work within the dynamics of a cross-functional team
• Strong communication skills
Desirable Additional Experience:
• ISO 13485 auditor qualification desirable
• Advanced wound care manufacturing an advantage
• Cleanroom experience an advantage
Ready to Make an Impact
APPLY NOW! Send us your CV and cover letter explaining why you’re the perfect fit.
Note: Due to high application volumes, only shortlisted candidates will be contacted. We reserve the right to close applications early. No agencies, please

Related Jobs

View all jobs

Mechanical Engineer

Project Engineer

Design Engineer

Trainee Process Engineer (Manufacturing)

Process Engineer

Software Engineer

Get the latest insights and jobs direct. Sign up for our newsletter.

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

Industry Insights

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

Portfolio Projects That Get You Hired for Biotech Jobs (With Real GitHub Examples)

Biotechnology is at the forefront of numerous scientific breakthroughs—from vaccine development to CRISPR-based gene editing—and data-driven methods now power much of the innovation in this space. If you’re aspiring to land a role in biotech—be it in drug discovery, genomics, immunology, or computational biology—an impressive portfolio can help you stand out in a fiercely competitive market. But what makes a biotech portfolio compelling? How can you prove your worth to a hiring manager who wants practical, hands-on skills in computational biology, wet-lab data analysis, or next-generation sequencing (NGS)? In this guide, we’ll explore: Why a biotech portfolio is essential for showcasing relevant skills. How to choose portfolio projects that align with emerging biotech roles. Real GitHub examples of projects that demonstrate an end-to-end approach. Tangible project ideas specific to biotechnology. Best practices for organising and presenting your work so that potential employers see your talents at a glance. By the end, you’ll have concrete steps to create a portfolio that highlights your value to recruiters and biotech companies. And, when you’re ready to take the next step, remember to upload your CV on BiotechnologyJobs.co.uk for direct exposure to employers who need your expertise.

Biotech Job Interview Warm‑Up: 30 Real R&D & Project‑Design Questions

The biotechnology sector is at the forefront of scientific innovation—encompassing everything from drug discovery and gene editing to agricultural improvements and environmental sustainability. It’s a field that combines cutting-edge research, regulated processes, and commercial acumen. As such, biotech job interviews can be both exciting and rigorous, often spanning technical, operational, and strategic discussions. If you’re gearing up for a biotech interview, be prepared for questions that dive into cell and molecular biology, bioinformatics, clinical trials, manufacturing regulations, and even data analysis. Beyond scientific expertise, recruiters are keen to see how you handle project planning, regulatory compliance, and cross-functional collaboration—especially if the position involves leadership or project management elements. Whether you’re seeking a lab-based R&D role, a regulatory affairs position, or a biotech project management opportunity, thorough preparation is essential. In this article, we’ll explore 30 real interview questions commonly asked in the biotech sector. By reviewing these questions and thinking through your responses, you’ll develop the confidence and clarity you need to showcase your talents effectively. For those looking for the latest biotech opportunities, head to www.biotechnologyjobs.co.uk. It’s a centralised place to discover exciting roles within the UK biotech landscape—covering everything from start-ups to large pharmaceutical companies. Let’s dive in and get you interview-ready.

Negotiating Your Biotech Job Offer: Equity, Bonuses & Perks Explained

How to Secure a Compensation Package That Reflects Your True Value in the UK’s Thriving Life Sciences Sector Introduction Biotechnology is one of the most dynamic and impactful sectors in today’s global economy—particularly in the UK, which boasts a thriving research ecosystem and a burgeoning community of innovative start-ups. From cutting-edge work on gene editing and CAR-T therapy to breakthroughs in diagnostics and personalised medicine, the biotech field promises vast opportunities for mid‑senior professionals to make a meaningful difference. However, with these opportunities comes the need for careful negotiation when evaluating a new role. Biotech companies—whether they’re large pharmaceutical giants or lean start-ups—often structure compensation packages that go far beyond simple salaries. These may include equity grants, performance-based bonuses, and a range of perks designed to attract top talent in a competitive market. Focusing solely on your base salary could mean missing out on substantial long-term rewards or lifestyle benefits. In biotech, your contributions might directly influence life-changing products, high-stakes clinical trials, or novel therapeutic approaches. Hence, your compensation should reflect both the immediate and future value you bring. This article aims to be your comprehensive guide to negotiating a biotech job offer in the UK. We’ll delve into why negotiation goes beyond salary, how equity functions in the biotech context, and how performance bonuses and other perks can amplify the overall value of your compensation. Geared for mid‑senior professionals, this guide offers actionable insights to help you secure a holistic compensation package that aligns with your expertise, future goals, and the impact you will have on advancing life sciences.