Quality Manager

Engineering    ·    Cambridge, United Kingdom    ·    Full time

Description

About BIOS Health:

BIOS is unlocking the potential of the nervous system in treating chronic disease by using AI-powered neural interfaces that can automatically read and write neural signals. The human nervous system carries vast quantities of data and scientists have long known that faulty signals in the nervous system play a key role in driving chronic diseases. By understanding and correcting these signals in real time, BIOS can treat chronic illnesses in an effective, automated, and personalised way, leading to seamlessly experienced healthcare. BIOS utilises its proprietary breakthroughs in AI and Machine Learning to translate the “language” of the nervous system for the first time. BIOS’ neural code is built on the world’s largest proprietary neural data set and is already in use clinically to enhance data from wearables used in remote chronic disease care.

BIOS is made up of a wide range of experts from neuroscience, machine learning, software engineering, applied biomaterials, biotechnology, medicine, and business and operations. The combined experience of the BIOS team extends to over 300 peer-reviewed publications, 10+ first of kind medical devices, and 6k+ clinical procedures.

We are looking for people who will fit into our diverse, fun and stimulating company team culture, who are focused on overcoming challenges, and want to grow along with the company. We are especially looking for candidates that share our values: enjoy solving hard problems; bring a unique perspective but become an active part of the BIOS team; respect what matters and do what’s right; and enjoy the challenge.

About the role:

We are looking for a quality manager to guide our medical device developments. This role will focus on device development and regulatory submission and certification, providing strategies for driving product quality and continuous improvement.

Main duties and responsibilities:

• Liaising and co-operating with Certification and Notified Bodies, working with external consultants as required
• QMS documentation and development, ensuring the QMS meets the current needs of the business, in line with industry standards and accreditation requirements
• Managing internal, external and supplier audits e.g. recruiting and training of internal auditors
• Working with Engineering and other teams to ensure compliance with design and change control processes, providing QA oversight to development projects
• Supporting device development activities such as compiling and managing technical files
• Developing risk management plans and activities
• Establishing and managing the quality processes, e.g. change control, CAPA, document control, supplier evaluation, post-market surveillance
• Preparing for and supporting clinical trial submissions
• Quality training throughout the business including inductions, QMS, quality processes, standards, regulations etc.
• Responsible for ensuring that any changes to standards or regulations are identified and communicated in a timely manner
• Primary interface for external auditors and regulatory agencies for on-site audits and follow-up.

Requirements

Essential skills and qualifications:

• Quality and product development experience within a medical device environment
• Knowledge and understanding of designing and testing products in accordance with applicable industry standards and regulatory requirements e.g. ISO 13485, EU Medical Device Regulation (MDR)
• Experience of using a formal, version-controlled document management system in a QA context
• Strong ability to effectively engage and influence stakeholders (i.e. operations, engineering, management, etc.)
• Highly organized, pro-active and self-motivated team leader
• Flexible rather than autocratic approach
• Degree Level in Engineering / Science / Technology or equivalent experience
• Ability to work autonomously and complete tasks under tight deadlines
• Good English Language skills. Appropriate UK qualification or SELT pass at B1 CEFR scale or confirmed Ecctis for degrees taught in English.

Desired skills and qualifications:

• A quality related CPD log showing formal training and development activities related to ISO standards and European Directives
• Strong knowledge of ISO 13485 & 21 CFR part 820
• Experience in leading an SME through ISO 13485:2016 transition, initial certification, or similar
• Knowledge of risk management planning and analysis (Hazard analysis, DFMEA etc.)

Benefits

We offer a competitive Salary, dependent on experience, and company share options.

Other benefits include:

• Hybrid working (office and remote) and flexible hours (outside of core hours)
• Healthcare and Dental insurance
• Enhanced Pension scheme
• A variety of well-being initiatives (incl. gym membership contribution, cycle maintenance scheme)
• Financial support for commuters through our season ticket loan scheme
• Great central Cambridge location with excellent transport links (incl. rail, bus, bike, scooters) and local amenities

Equal Opportunities:

BIOS is committed to equal employment opportunities. We welcome applications from all qualified applicants who will receive equal treatment regardless of age, disability, gender reassignment, marital or civil partner status, pregnancy or maternity, race, nationality, ethnic or national origin, religion or belief, gender or sexual orientation.