Quality Specialist

3 months ago

Cambridge, United Kingdom 52North - creators of Neutrocheck® Full time

About 52North


Crowned 'MedTech Company of the Year' in the 2023 Cambridge Independent Science and Technology Awards, 52North is a med-tech company aiming to reinvent healthcare journeys for all people across the world.


Our mission is to help people live better lives, and we do this through innovating, collaborating and using cutting-edge technology that centre around the people who will engage with it: whether they are people living with disease, care givers, doctors, paramedics or nurses. By integrating cutting-edge technology with a human-centred approach, we're dedicated to revolutionising patient experiences and setting new industry standards.


Our flagship product, Neutrocheck, was selected as one of a handful of technologies globally for the UK government’s first Innovative Devices Access Pathway (IDAP) pilot programme, providing direct and regular access to regulators and reimbursement authorities.


We are at an exciting and fast-paced stage of the company’s growth and are looking for a Quality Specialist to join our collaborative and interdisciplinary team to manage our QMS on a day-to-day basis and support regulatory activities. Apply now if you are passionate about ensuring quality for state-of-the-art technology to make healthcare systems more efficient and transform the lives of patients around the world.


Position Overview


Key Responsibilities:


As Quality Specialist you will be responsible for:

  • Delivering on company quality objectives
  • Administering all aspects of the QMS on a day-to-day basis, for example: Sending QMS records for approval, ensuring quality training is up to date for all staff and that staff understand and follow QMS procedures, ensuring suppliers are approved and managed according to our QMS, leading on internal and external audits, leading on quality activities e.g. change control, non-conformances and CAPAs, monitoring QMS performance and identifying and implementing improvements, management reviews
  • Completing QMS scope expansion to include manufacturing and post-market surveillance.
  • Facilitating transition to a full eQMS solution to improve efficiency.
  • Developing new policies and procedures to help the organisation work towards reaching other relevant QMS accreditations e.g. MDSAP certification, ISO27001


As Quality Specialist, you will also support the preparation of technical and design history files for 52North’s products by:

  • Contributing to product technical and quality documentation e.g. as author or document manager
  • Supporting the regulatory team with regulatory activities e.g. registering devices, preparing communications for interactions with regulatory bodies, research to understand specific requirements.


Qualifications and experience


Essential:

  • Degree in law, medicine, pharmacy, engineering or another relevant scientific discipline
  • At least 3 years’ experience working in an ISO13485-certified quality management system for devices that require review and approval by authorities (e.g. FDA, Notified Body, UK Approved Bodies).
  • Excellent attention to detail, organisational, team-working and communication skills.
  • Experience managing a quality system, ISO compliance and internal and external audits.
  • Proactive thinking, designing and implementing processes from scratch and working collaboratively in a small, fast-paced and interdisciplinary team.
  • Motivation to learn and continuous improvement mindset.


Preferred:

  • Experience working with technical files and design history files for medical devices e.g. authoring documents and/or project managing document creation and review.
  • Experience working with In Vitro Diagnostics and self-tests
  • Experience working with quality for Software as a Medical Device products and/or connected devices
  • Experience supporting a Quality Management Rep
  • Hands-on experience with ISO13485 audits


52North is an equal opportunity employer and is committed to providing equal employment opportunities to all employees and applicants for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, age, disability, or any other characteristics protected by law.


Benefits


At 52North, we believe that our team should be taken care of both in and outside of the office. We offer a robust benefits package, carefully designed to ensure our team members are supported in all aspects of their lives. Our benefits include:


  • Hybrid Working: Enjoy the flexibility of working from home or in our beautiful office space.
  • Flexible Schedule: We understand that everyone has different needs and rhythms. That is why we offer a flexible work schedule.
  • Generous Holiday Allowance: We offer 28 days of paid holiday plus bank holidays every year. On top of that, you will get an extra day off for every two years of service with us.
  • Maternity, Paternity and Adoption Policies: We have comprehensive policies for maternity, paternity, shared parental leave and adoption to support our team members in these life-changing moments.
  • EMI Share Option Scheme: We want our team to be part of our long-term success, so we provide participation in an EMI share option scheme.
  • Pension Scheme: We offer a NEST pension scheme with generous employer contributions.
  • Health Insurance: Our Vitality health insurance provides generous coverage, including physiotherapy, mental health services, and unlimited virtual GP consultations.
  • Dental and Optical Coverage: We cover dental and optical expenses because we know how important complete healthcare is.
  • Wellbeing Engagement Programme: We promote a healthy lifestyle by providing a 50% discount on certain gym memberships and other wellness resources.
  • Social Activities: We foster a close-knit community with social activities throughout the year and multi-day group retreats.
  • Office Perks: Our office is a 15-minute walk from the historical city centre of Cambridge, well connected with public transport and Park & Ride. Enjoy free biscuits, cake, tea, and coffee and soak in the beautiful countryside views that our office offers.


Join us at 52North and enjoy these benefits as you work in an environment that fosters growth and encourages work-life balance.

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