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Quality Manager
2 months ago
At Crux, we are seeking a passionate and proactive Quality Manager who is driven by continuous improvement. In this role, you will maintain and elevate our existing systems while actively identifying areas for enhancement. You will have a keen eye for detail and a strategic mindset to ensure our Quality Management System (QMS) is best-in-class.
This is a pivotal role where you’ll drive initiatives that improve processes, ensuring consistent compliance with both internal and external requirements. Your leadership will ensure we not only meet but exceed the stringent standards of the medical device industry.
We are looking for someone who not only has the expertise but also the drive to make things better. You should be passionate about quality and always looking for opportunities to enhance processes and systems.
Principal Responsibilities
- Quality Management System (QMS): Maintain, refine, and continuously improve Crux’s QMS, identifying opportunities to elevate it to best-in-class.
- Process Improvement: Proactively identify areas where processes can be improved, then develop and implement effective, scalable solutions.
- ISO & Regulatory Compliance: Ensure QMS documentation remains up-to-date and compliant with ISO 9001, ISO 13485 standards, and global regulatory frameworks such as FDA regulations (21 CFR Part 820) and EU Medical Device Regulation (MDR).
- Risk Management: Lead the development and implementation of risk management processes in accordance with ISO 14971 to identify, assess, and mitigate risks associated with medical device development.
- Legislation Monitoring: Stay ahead of relevant, current, and emerging legislation to ensure our systems are compliant.
- CAPA & Change Control: Manage the CAPA system, overseeing the change control process for QMS SOPs and related documentation.
- Internal Audits: Conduct thorough internal project and QMS audits and ensure continuous improvement in audit effectiveness.
- External Audits: Serve as the primary representative for all external body and customer audits, ensuring a smooth audit process and aiming for outstanding results.
- Client Support: Respond to client regulatory and quality requests, including supporting strategic questionnaires, with a focus on enhancing client satisfaction and service delivery.
- Regulatory & Quality Queries: Support project teams by providing expert guidance on regulatory and quality requirements, ensuring compliance during the development of medical devices and other products.
What We’re Looking For…
Essential:
- Proven experience managing and improving Quality Management Systems (QMS).
- Strong understanding of ISO 9001, ISO 13485 standards, and regulatory frameworks like FDA 21 CFR Part 820 and EU Medical Device Regulation (MDR).
- Expertise in risk management, including proficiency in ISO 14971 for managing medical device risks.
- Experience conducting internal audits and managing external audits, with a focus on continuous improvement.
- Strong attention to detail.
- A passion for continuous improvement and a drive to make a positive impact across all areas of quality management.
Location: Bristol, UK
About Crux:
Crux are world-leaders in the design, simulation and analysis of medical devices and consumer products; working as a trusted partner to many medical companies and household brand names, our projects touch lives by delivering a vast array of products to global markets.
We are a dynamic and fast-growing engineering consultancy that takes pride in its outstanding work and a warm and supportive workplace. As part of our team, you’ll be working within a family of high-performing expert engineers. Our strong community is built upon effective communication and happy employees, collaboration in project work and regular social events are the norm.
Interested?
Email your CV and covering letter to:
careers@cruxproductdesign.com
Please title your correspondence 'Quality Manager (Bristol, UK)'. We look forward to hearing from you.
