Job Title:
A Quality Specialist to Manage QMS and Support Regulatory Activities
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.
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.
Key Responsibilities:
* Delivering on company quality objectives
* Administering all aspects of the QMS, including sending records for approval, ensuring quality training is up to date, and managing suppliers
* 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
Requirements:
* 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
* Excellent attention to detail, organisational, team-working and communication skills
* Experience managing a quality system, ISO compliance and internal and external audits
* Motivation to learn and continuous improvement mindset
Preferred Qualifications:
* Experience working with technical files and design history files for medical devices
* 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
Salary:
£60,000 - £80,000 per annum
Benefits:
* 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.
* 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.