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- Tasks: Ensure quality assurance throughout design and development of cutting-edge gene-sequencing technology.
- Company: Join a leading biotech firm revolutionising gene-sequencing with innovative nanopore technology.
- Benefits: Enjoy a dynamic work environment, potential for remote work, and opportunities for professional growth.
- Why this job: Be part of a mission-driven team making a real impact in healthcare and technology.
- Qualifications: HND or higher in engineering; 10+ years in quality roles, preferably in electronic products.
- Other info: Ideal for those passionate about quality assurance in a fast-paced, innovative setting.
The predicted salary is between 36000 - 60000 £ per year.
A leading biotechnology company develops, manufactures, and sells products based on a unique and market-leading nanopore-based next generation gene-sequencing (NGS) technology. In addition to offering these technologies for research use only (RUO) applications, the company also markets in vitro diagnostic (IVD) instruments using the same advanced NGS platform. The company develops its own assays and reagents and works in close collaboration with a broad network of third parties to support assay development. Design and manufacturing are based in Oxford, while the company's products are marketed globally for both RUO and IVD purposes. As a result, its instruments and assays must comply with applicable regulations in all sales territories, requiring submissions to relevant healthcare authorities. To ensure regulatory compliance, the company operates two Quality Management Systems (ISO 13485 & ISO 9001).
About the Role
This role will focus on providing quality assurance support throughout the Design & Development process, with a particular focus on electronic sequencers and software.
Key Responsibilities
- Conduct quality reviews of processes, work instructions, and documents (e.g., requirements, specifications, design outputs, drawings, material specifications, labelling, test plans/protocols, test reports) and other quality records.
- Participate in design reviews and contribute to risk management and production process development.
- Conduct internal audits as required.
- Review and approve all design and development-related processes, documents, and records.
- Support the maintenance of ISO 9001 and ISO 13485 certifications through a variety of quality-related activities.
- Build strong working relationships with manufacturing teams.
- Support and, when necessary, lead internal and external audits (including customer, regulatory, and certification audits).
Qualifications / Education
- HND level qualification or higher in a relevant engineering discipline (e.g., electronics or mechanical engineering).
- Desirable: Experience or understanding of software development or control systems.
- Lead auditor qualification.
Experience
- Essential: At least 10 years of experience in a design quality, test, or general quality role related to electronic products (scientific or medical) within a certified ISO 9001 or ISO 13485 environment.
- Strong knowledge of design control, verification, validation, change control, non-conformance management, CAPA, and statistical techniques.
- Quality assurance experience related to electro-mechanical assemblies, PCBA design/manufacturing, labeling, SMD processes, and collaboration with R&D teams.
- Proven understanding of ISO 13485 (especially Product Realisation), ISO 14971, document control, non-conformity, and CAPA.
- Experience in using data analysis to monitor performance and drive quality system improvements.
- Desirable: Experience in the IVD or medical device industry is advantageous but not essential; a solid grasp of quality principles and their application in product development is key.
- Familiarity with CE audits or FDA inspections from a manufacturer's perspective.
- Expertise in process validation, traceability of materials and records.
- Knowledge of firmware/software development aligned with IEC62304.
- Experience with injection moulding, overmoulding, and computer-controlled robotic production processes.
- Understanding of process risk management (PFMEA).
Knowledge / Skills / Abilities
- In-depth knowledge of ISO standards (such as ISO 9001 or ISO 13485).
- Demonstrated ability to work with external partners and stakeholders while balancing risk and commercial interests.
- Strong interpersonal and organizational skills, with the ability to influence at a senior level.
- Proven capability to build effective internal and external relationships.
Attitude / Other Requirements
- Adaptable and proactive mindset with experience in fast-paced, agile work environments.
- Goal-oriented, with the ability to develop and implement practical solutions.
- Effective communicator, including the ability to explain complex concepts to non-experts.
- Excellent written and spoken English.
- High attention to detail and strong risk-based prioritization skills.
Quality Assurance Specialist | Oxford, UK employer: Morgan McKinley
Contact Detail:
Morgan McKinley Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Assurance Specialist | Oxford, UK
✨Tip Number 1
Familiarise yourself with ISO 9001 and ISO 13485 standards, as these are crucial for the role. Understanding the nuances of these regulations will not only help you in interviews but also demonstrate your commitment to quality assurance.
✨Tip Number 2
Network with professionals in the biotechnology and quality assurance fields. Attend industry events or webinars to connect with people who work in similar roles, as they can provide insights and potentially refer you to opportunities at our company.
✨Tip Number 3
Brush up on your knowledge of electronic products and their design processes. Being able to discuss specific examples of quality assurance in electronic or medical devices will set you apart during discussions with our hiring team.
✨Tip Number 4
Prepare to discuss your experience with internal audits and risk management. Highlighting your past successes in these areas will show us that you have the practical skills needed to excel in this Quality Assurance Specialist role.
We think you need these skills to ace Quality Assurance Specialist | Oxford, UK
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in quality assurance, particularly in design quality and electronic products. Emphasise your familiarity with ISO 9001 and ISO 13485 standards, as well as any specific skills related to the biotechnology or medical device industry.
Craft a Compelling Cover Letter: In your cover letter, express your passion for quality assurance and how your background aligns with the company's focus on innovative gene-sequencing technology. Mention specific experiences that demonstrate your ability to conduct quality reviews and support compliance with regulatory standards.
Highlight Relevant Qualifications: Clearly state your educational qualifications, especially if you have an HND or higher in engineering. If you possess a lead auditor qualification or experience in software development, make sure to include these details as they are desirable for the role.
Showcase Your Soft Skills: Quality assurance roles require strong interpersonal and organisational skills. Use examples from your past experiences to illustrate your ability to build relationships with teams and stakeholders, and your capability to communicate complex concepts effectively.
How to prepare for a job interview at Morgan McKinley
✨Know Your Standards
Familiarise yourself with ISO 9001 and ISO 13485 standards, as these are crucial for the role. Be prepared to discuss how you've applied these standards in your previous work, especially in relation to quality assurance processes.
✨Showcase Your Experience
Highlight your 10+ years of experience in design quality or related roles. Prepare specific examples of projects where you contributed to quality reviews, audits, or compliance activities, particularly in electronic products.
✨Demonstrate Technical Knowledge
Be ready to discuss your understanding of design control, verification, and validation processes. If you have experience with software development or control systems, make sure to mention it, as this is a desirable skill for the position.
✨Build Relationships
Emphasise your ability to build strong working relationships with manufacturing teams and external partners. Share examples of how you've successfully collaborated with others to achieve quality objectives, as teamwork is key in this role.
