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For Companies At a Glance
- Tasks: Lead quality management for production sites, ensuring compliance and fostering a quality culture.
- Company: Join Oxford Nanopore Technologies, a pioneer in nanopore-based gene sequencing technology with global impact.
- Benefits: Enjoy a dynamic work environment, opportunities for growth, and the chance to make a difference.
- Why this job: Be part of an innovative team shaping the future of molecular analysis and healthcare.
- Qualifications: HND or higher in science/engineering; 10+ years in quality management; lead auditor qualification preferred.
- Other info: Experience in IVD devices is a plus, but strong quality principles are essential.
The predicted salary is between 48000 - 84000 £ per year.
This job is brought to you by Jobs/Redefined, the UK\’s leading over-50s age inclusive jobs board.
Job Description
About Us
Oxford Nanopore Technologies (ONT) and its subsidiary Oxford Nanopore Diagnostics (OND) develop, manufacture, and sell products based on ONT\’s unique and market-leading nanopore-based next-generation gene-sequencing (NGS) technology. Our products support both research use and IVD applications, and we also collaborate with a wide range of third parties for assay development. With design and manufacturing based in Oxford and global marketing, our IVD instruments and assays are subject to international regulations. OND and ONT operate two Quality Management Systems: ISO 13485 (OND) and ISO 9001 (ONT).
The Role
As part of our expanding quality function, we\\\’re establishing a dedicated QA and QC team focused on our four production sites in Abingdon and Harwell. This role manages both QA (2 heads) and QC (1 Lead and 2 heads), reporting directly to the Senior Director of Quality Assurance. You\\\’ll be responsible for supporting overall Production/Operations Quality Management across resources, facilities, environmental conditions, process control, validation, material specifications, inspections, internal/external audits, CAPA, change control, and certificate of conformance activities.
You will also
- Provide primary support to the Senior Director of QA in managing and executing the QMS.
- Develop deep relationships with production functions and foster a strong quality culture.
- Review and approve all production-related processes, documents, and records.
Key Responsibilities
- Manage all QA and QC functions across UK direct manufacturing sites.
- Act as senior deputy to the Senior Director of QA, representing them in Production-related matters.
- Support the Production QA & QC team in achieving objectives and maintaining ISO 9001 & 13485 accreditation.
- Establish strong relationships with manufacturing teams.
- Support or lead internal and external audits (regulatory, customer, certification).
- Perform any other reasonable duties as required.
PERSON SPECIFICATION
Essential Qualifications & Experience
- HND or higher in a relevant science or engineering discipline (e.g., electronics or mechanical).
- A minimum of 10 years\\\’ experience managing a production quality team across electronics and cleanroom environments within ISO 9001, 13485, or similar regulated sectors (medical device, aerospace, pharma, etc.).
Experience with:
- PCB, loom/wiring manufacturing
- QC (metalwork, labelling, PCBAs, chemical supplies, etc.)
- Wet processes, injection/overmoulding
- Robotic/computer-controlled production
- Understanding of electronic/software devices, SaMD, reagents, packaging, labelling, risk/change management.
- Demonstrated team leadership (teams of >5) and performance monitoring.
- Strong grasp of quality principles in complex manufacturing settings.
- Deep knowledge of process validation, control, traceability of records/materials.
Desirable
- Lead auditor qualification (ISO 13485/IVD).
- CE audit/FDA inspection experience.
- Experience with wafer chip manufacturing.
- Understanding of process risk management (PFMEA).
Skills & Abilities
- Detailed working knowledge of ISO 9001 or ISO 13485.
- Strong external stakeholder management with a balanced risk/commercial approach.
- Excellent interpersonal and organisational skills.
- Influential communicator at senior levels.
Attitude & Requirements
- Goal-oriented, solution-focused, and adaptable in fast-paced, agile environments.
- Highly effective communicator to non-expert groups.
- Excellent written and spoken English.
- High attention to detail with risk-based prioritisation
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About Us
Oxford Nanopore Technologies: Our goal is to bring the widest benefits to society through enabling the analysis of anything, by anyone, anywhere. The company has developed a new generation of nanopore-based sensing technology for faster, information rich, accessible and affordable molecular analysis. The first application is DNA/RNA sequencing, and the technology is in development for the analysis of other types of molecules including proteins. The technology is used to understand and characterise the biology of humans and diseases such as cancer, plants, animals, bacteria, viruses, and whole environments. With a thriving culture of ambition and strong innovation goals, Oxford Nanopore is a UK headquartered company with global operations and customers in more than 125 countries.
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Manufacturing Quality Manager employer: Oxford Nanopore Technologies
Contact Detail:
Oxford Nanopore Technologies Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Manufacturing Quality Manager
✨Tip Number 1
Familiarise yourself with ISO 9001 and ISO 13485 standards, as these are crucial for the Manufacturing Quality Manager role. Understanding these regulations will not only help you in interviews but also demonstrate your commitment to quality management.
✨Tip Number 2
Network with professionals in the medical device industry, especially those with experience in quality assurance. Attend relevant conferences or webinars to make connections and gain insights that could give you an edge during the application process.
✨Tip Number 3
Prepare to discuss specific examples of how you've led quality teams and managed compliance in previous roles. Highlighting your leadership experience and ability to drive change will resonate well with the hiring team.
✨Tip Number 4
Research Oxford Nanopore Technologies and their products thoroughly. Understanding their technology and market position will allow you to tailor your discussions and show genuine interest in contributing to their mission.
We think you need these skills to ace Manufacturing Quality Manager
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in quality management, particularly in ISO 9001 and 13485 environments. Emphasise your leadership roles and any specific achievements in managing production quality teams.
Craft a Compelling Cover Letter: In your cover letter, express your passion for quality assurance in manufacturing. Mention how your background aligns with the responsibilities of the Manufacturing Quality Manager role and how you can contribute to fostering a quality culture at Oxford Nanopore Technologies.
Highlight Relevant Experience: When detailing your work history, focus on experiences that demonstrate your understanding of cleanroom processes, PCB manufacture, and other relevant areas mentioned in the job description. Use specific examples to illustrate your expertise.
Showcase Your Interpersonal Skills: Given the importance of building relationships across teams, include examples of how you've successfully collaborated with various stakeholders in previous roles. Highlight your communication skills and ability to influence at senior levels.
How to prepare for a job interview at Oxford Nanopore Technologies
✨Know Your Quality Standards
Familiarise yourself with ISO 9001 and ISO 13485 standards, as these are crucial for the role. Be prepared to discuss how you've implemented these standards in previous positions and how they relate to the manufacturing processes at Oxford Nanopore.
✨Demonstrate Leadership Experience
Highlight your experience in managing quality teams, especially in a production environment. Share specific examples of how you've led teams to achieve quality objectives and maintained compliance with regulations.
✨Showcase Your Technical Knowledge
Be ready to discuss your understanding of various manufacturing processes, such as PCB manufacture and cleanroom operations. This will demonstrate your capability to manage quality across different production sites effectively.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving skills in real-world scenarios. Think about past challenges you've faced in quality management and how you resolved them, particularly in fast-paced environments.
