Team Consulting is an employee-owned business, set in the heart of the Ickleton countryside, just south of Cambridge. We encourage a hybrid working model and a culture that supports flexible working.

We are looking for an experienced Product Risk Manager, with a background in Quality Engineering (QE), to join and help further develop our established QE team. The successful candidate will be responsible for oversight of product risk management activities, carried out as part of Team’s internationally renowned medical device development services. The role is also responsible for continuous improvement of Team’s risk management tools and processes.

The Product Risk Manager will also carry out QE activities across the business, including supporting and coaching technical colleagues to ensure the implementation of and adherence to our quality management systems, and undertaking business development activities to articulate the QE offering.

Reporting to the Head of QE, success in the role will require close collaboration within multi-disciplinary project teams, as well as interaction with QE counterparts in client organisations.

Key Duties include:

Risk Management

  • Leading product / device risk management activities and ensuring seamless integration with clients’ processes
  • Ensuring a consistent approach to risk management across all disciplines in the company
  • Training and coaching staff on current and future risk management procedures and tools
  • Maintaining up to date knowledge and understanding of regulatory requirements, international standards and best practice in the field
  • Developing risk management tools and operating procedures for compliance with industry standards

Quality Engineering

  • Ensuring compliance to Team’s QMS, Client QMS and agreed standards
  • Coaching and supporting colleagues from around the business in the implementation and pragmatic application of the QMS on delivery of consultancy & development projects.
  • Supporting Team QA during client and third party audits
  • Contributing to the continuous improvements of our quality systems and tools to positively impact the delivery of our client projects
This is a great opportunity for someone looking to take the next step in their career, to help guide the development of the team and the positioning of this capability both internally and with clients.


Qualifications and Skills

Essential

  • HND in quality or relevant degree, e.g. Engineering or Science
  • A minimum experience of 5 years in combination drug delivery, medical device product development and device risk management activities
  • Detailed knowledge of ISO 14971, ISO 13485, FDA QSR and Medical Device Directive
  • Experience of three or more of the following:
    • Creation of risk management file
    • Facilitation of use related risk assessment
    • Facilitation of system risk assessment
    • Facilitation of design risk assessment
    • Facilitation of software risk assessment
    • Facilitation of process risk assessment
  • Experience of project quality management
  • Experience of working in a project-based organisation
  • Demonstrable experience in quality assurance
  • Experience of creating and managing elements of a Design History File / Technical File
  • Awareness of medical industry and regulatory trends

Desirable

  • Knowledge of other QMS; IEC 62366 and 62304
  • Awareness of industry trends and developments
  • Experience of working in a consulting environment
  • Experience in creating and managing Design History / Technical Files

Leadership / Consultancy Skills

Essential

  • Excellent communication skills
  • Excellent analytical ability - data gathering, analysis and presentation of conclusions to the team
  • Ability to liaise with colleagues, clients and sub-contractors at technical and non-technical levels, as well as all levels of seniority
  • Ability to build and sustain productive working relationships with colleagues
  • Commitment to quality and excellent attention to detail
  • Eagerness to learn new skills and a commitment to continuous professional development

Desirable

  • Project management
  • Excellent analytical ability - data gathering, analysis and presentation of conclusions to the team
  • Structured and methodical problem solving

Personal Qualities

  • Collaborates effectively and is a good team player, including being aware of own limitations and the strengths of others
  • Dynamic with an eagerness to continuously learn and drive best practice
  • Actively shares own knowledge
  • Enthusiastic with a positive outlook
  • Adaptable and pragmatic
  • Self-sufficient and willing to take responsibility for own tasks
  • Calm under pressure
  • Shows integrity and honesty at all times
  • Respectful of others’ opinions and contributions and is supportive of colleagues

Additional Role Requirements and Working Patterns

Willingness to travel occasionally, to client locations in the UK, Europe and further afield.

Equal Opportunities

Team values equality, diversity and inclusion in employment and recruitment. We are committed to promoting equal opportunities and an inclusive community, where our talented people respect and value the contributions, skills, and abilities of others.

We want our people to succeed on merit, treating individuals equally, including making decisions and providing encouragement and opportunities relating to recruitment, career development and retention in a fair and consistent manner.

Our aim is a workplace free from all forms of bullying, harassment or victimisation, and unlawful or unfair discrimination on the grounds of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief, and marriage and civil partnerships.

Application Form





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