Job Description

Job title: Quality Engineer

Location: London

Salary: £30,000 – 50,000/ year + bonus + benefits

Basis: Full time (40 hours)

About us

medHF is a Human Factors Engineering consultancy that works to support some of the world’s most successful medical device and pharmaceutical companies to develop and gain regulatory approval of safe and effective medical products. To support its clients medHF performs usability studies across Europe and the US, and provides services in use related risk management, instructions for use development, threshold analysis and preparation of regulatory documentation related to human factors engineering.

medHF is an ISO13485:2016 certified provider of services to medical device and pharmaceutical companies and operates from bases in Basel (Switzerland), Columbus (US), London (UK) and Grenoble (France).

Our need

We are looking for a Quality Engineer to support the company’s operations and maintain an independent quality overview of the company’s processes and outputs. Quality and compliance are at the heart of our operation and are of importance to our clients.

What you will be doing:

• Working as part of a Human Factors study team you will review study documentation for conformance to company procedures and applicable GxP principles, including:
• Reviewing study protocols and associated documentation including informed consent forms, data collection forms.
• Performing integrity checks on records.
• Reviewing study reports.
• Reviewing health authority study protocol review advice to ensure comments are appropriately investigated and actioned.
• Preparing ethics committee/ IRB study submissions and liaising on changes and queries.
• Performing validation on study databases in accordance with company procedures.
• Managing training records and providing training to employees.
• Manage supplier qualification and evaluation process.
• Manage the implementation of and development of the company’s quality system, including revising and authoring new SOPs, policies and
• Participate and support company supplier and certification body audits.
• Execute the company’s non-conformity management and CAPA process.
• Review and control proposals for accuracy and consistency

Essential:

• Detail focus and diligence.
• Prior experience working in Quality for Medical Devices and/or Combination Product development or clinical trial quality.
• Knowledge of Medical Device/ Combination Product regulations.
• Knowledge of Good Documentation Practices (GDP).
• Good understanding of ISO 13485.

Desirable:

• Auditing experience, both performing and hosting.
• Understanding of Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP).
• Knowledge of ISO 14971.
• Clinical trial experience.
• Understanding of IEC 62366 and human factors engineering guidelines.

Job Type: Full-time

Salary: £30,000.00-£50,000.00 per year

Benefits:

• Company pension
• Flexitime
• Life insurance
• Sick pay
• Work from home

Schedule:

• Flexitime
• Monday to Friday

Supplemental pay types:

• Yearly bonus

Work Location: In person

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