Brighton, East Sussex (GB)
Starting rate of £30,160/annum pro rata = £14.50/hour for a 24 hours per week
18 Dec 2020
17 Jan 2021
Part Time
Contract Type
Experience Level

Quality Systems Manager – Part Time

Mooncup Ltd is a multi- award-winning ethical business manufacturing the Mooncup®- the world’s first silicone menstrual cup – and distributing it internationally. A true game-changer, the Mooncup® a one-off purchase made in the UK, that puts a stop to the waste, inconvenience and cost of disposable sanitary protection. Mooncup Ltd is an Employee Owned Business looking for an experienced Quality Systems Manager to join our committed seventeen-strong team.

Job Description

The successful candidate will be responsible for the management, maintenance and continuous improvement of the ISO13485 and FDA 21 CFR 820 Mooncup Quality Management System acting as management representative. Responsible for our continued compliance to regulatory requirements and international standards, they will ensure all documents and procedures are in place, current and relevant, as well as carrying out an annual internal audit schedule, working with designated external certification bodies as appropriate. The post holder will be expected to demonstrate previous experience managing an ISO 13485 Quality Management System.

Person specification

  • Experience in managing an ISO 13485 Quality Management System is essential and some experience of a FDA 21 CFR 820 Quality Management System would be ideal
  • Experience in auditing a Quality Management System and managing audit programmes is essential
  • Excellent IT skills and a good working knowledge of Microsoft Office (Excel, Outlook, Word)
  • Experience of using a Customer Relationship Management System
  • Excellent organisational skills, with a methodical approach and a high level of attention to detail
  • Strong documentation skills
  • Clear and friendly written and oral communication skills
  • Flexible and happy to work as part of a team
  • Happy to ask for advice and work collaboratively
  • Sensitivity to the operational restrictions of a small business
  • Awareness of environmental issues

Your responsibilities:

Quality Management System

  • Organising and maintaining our controlled document system in line with our Quality Management System
  • Regular review of all Controlled Documents to ensure they are relevant and current
  • Maintaining the Mooncup Quality Manual and Controlled Documents Index
  • Approving Controlled Documents
  • Supporting all departments in maintaining their documentation and processes
  • Writing companywide procedures and work instructions
  • Acting as the Management Representative for the Quality Management System
  • Auditing the Quality Management System in line with ISO13485 and FDA 21 CFR 820
  • Hosting and facilitating external audits and visits from regulatory bodies
  • Working with the designated ISO external certification body
  • Ensuring changes to the relevant standards are adopted in a timely manner
  • Ensuring the Device Master Record documentation is kept up to date
  • Organising and delivering training on the Quality Management System for all employees
  • Software validation in line with company procedures
  • Managing the corrective and preventive action process, coordinating CAPA root causes and corrective actions, with follow up checks to verify implementation
  • Maintaining the Hazard Matrix and risk file and organising regular risk review meetings
  • Organising either a Quality meeting or a Management Review meeting once a quarter
  • Monitoring regulatory requirements in new markets the product is to be sold in and working with the team to ensure they are met

Stock Management

  • Responsible for the quality of all Mooncup® and MCUK® products, packaging, instructions for use and printed materials
  • Ensuring ‘Goods In’ checks are carried out for all stock and resolving any issues in line with the Quality Management System

Supplier Management and Quality Control

  • Maintaining relationships with our major suppliers – carrying out supplier reviews and UK factory visits as required
  • Organising recalls if necessary
  • Dealing with product issues arising after dispatch in line with our Quality Control System
  • Producing a quarterly report of product issues and delivery feedback in line with our Quality Control System
  • Dealing with quality related issues with our subcontract manufacturer
  • Audits of our subcontract manufacturer
  • Helping to source new suppliers of goods and services where required

Other duties include

  • FDA 21 CFR 820 Registration and compliance
  • Monitor and maintain UDI compliance for FDA 21 CFR 820 purposes
  • Work with Customer Service department to deal with customer complaints (Cat 1 & 2)
  • Attending and contributing to bi- monthly board meetings, team meetings, department meetings and other meetings as required
  • Risk Assessment and Risk Management: A familiarity with the Risk Management standard ISO 14971 will be useful for this role
  • Liaising with subcontract manufacturer on technical questions from customer service
  • Co ordinating medical device reporting of Category 1 complaints
  • Supporting the Company Directors with data protection compliance duties, including data audits
  • Maintaining company databases using ACT and Excel as required
  • Ad-hoc: ready to roll up your sleeves and help the team where necessary

The successful applicant will join a friendly, happy team and will receive the following benefits:

  • Starting rate of £30,160/annum pro rata = £14.50/hour for a 24 hours per week
  • Permanent position, ideally 9am – 5pm 3 days a week, including paid lunch break.
  • 33 days paid holiday per year (4 weeks annual leave, plus 8 bank holidays and 5 office closure days over Christmas) pro rata
  • Opportunity to join and collaborate in the running of an employee owned business recently rated among the UK’s top 50 Ethical Businesses and Brands. For Information on what this means go to employeeownership.co.uk
  • Company pension scheme and potential for annual profit-related team bonus.
  • Conveniently located offices near Brighton station. A mix of office and Working from Home may be required in line with government guidelines

To apply for this vacancy please complete the following forms and return by email to: contact@mooncup.co.uk

Please complete these forms for your application to be considered:


Application for Employment

Application Deadline: 9am on January 13th 2021

First round interviews: 27th/28th January 2021

Second round of interviews 4th February 2021 (face to face following government guidelines for social distancing)