Quality Engineer - Design Assurance

GET STAFFED ONLINE RECRUITMENT LIMITED; Bedford; Hybrid; GBP 35,000 - 40,000; Full time

Job summary

A leading company in advanced consumer diagnostic products seeks a Quality Engineer - Design Assurance to join their Quality team. This role focuses on ensuring compliance with quality standards and regulations within a medical device environment, offering a competitive salary and hybrid working options.

Benefits

Competitive salary and bonus

Hybrid working with flexibility

25 days paid annual leave plus bank holidays

Company pension scheme

Private Medical Insurance

Enhanced maternity and paternity pay

Health and Wellbeing programme

Life assurance

Free electrical car charging points

Free parking

Qualifications

• Experience working within a medical device environment.
• Working knowledge of ISO 13485.
• Desirable: Knowledge of US FDA 21 CFR 820.

Responsibilities

• Support compliance of Innovation projects to required standards.
• Perform general Quality Assurance duties.
• Ensure compliance with ISO 13485 and other regulations.

Skills

Quality Assurance

Communication

Documentation

Device Design Change Control

Education

Experience in medical device environment

Knowledge of ISO 13485

Job description

Quality Engineer - Design Assurance
Location: Bedford, Hybrid
Contract: Full time, permanent
Salary: £35,000 - £40,000 + Benefits

Our client is a world leader in the research, design and supply of advanced consumer diagnostic products. They are a joint venture and one of their brands are recognised all over the world as providing accurate home pregnancy and fertility monitoring tests.

Due to internal promotion, they are looking for a Quality Engineer - Design Assurance to join their Quality team on a permanent, full-time contract.

The role will be based at their Innovation Centre in Bedford, UK with option for Hybrid Working.

The Quality Engineer’s focus is supporting compliance of our client’s Innovation projects to all required standards and regulations supporting compliance of Quality activities relating to Design Assurance including Documentation and Device Design Change Control across areas of the business including Concept Innovation, New Product Introductions (NPI), Transfer to Manufacturing and Software as a Medical Device. The role holder will also perform general Quality Assurance duties as required in support of fulfilment of the Quality Objectives.

The role works within an In-Vitro Diagnostic Quality Management System (QMS) and complies with ISO 13485, Council Directive 98/79/EC, In-Vitro Diagnostic Medical Device Regulation 2017/746, US FDA 21 CFR Part 820 and other worldwide regulatory and compliance standards.

Our client is looking for someone who has experience of working within a medical device environment with working knowledge of ISO 13485. Applicants must also have a passion for quality and design assurance and be able to demonstrate excellent communication skills with the ability to build effective working relationships.

Working knowledge of software as a medical device is desirable along with working knowledge of US FDA 21 CFR 820, EU IVD Directive 98/79/EC or EU MDD Directive 93/42/EEC.

They can offer you:

• Competitive salary and bonus
• Hybrid working with flexibility
• 25 days paid annual leave plus bank holidays
• Company pension scheme with competitive employer contribution
• Private Medical Insurance with additional Medical Cash Plan
• Enhanced maternity and paternity pay
• Company supported employee Health and Wellbeing programme
• Life assurance
• Free electrical car charging points
• Free parking
• Beautiful parkland setting with excellent transportation links to Cambridge, Milton Keynes Northampton and London

You must have the right to work in the UK. Our client is not able to provide sponsorship for this role.

They are an equal opportunity employer and value diversity. They do not discriminate on the basis of race, religion, colour, national origin, gender, sexual orientation, age, marital status or disability status.

The Company

Our client is a world leader in the research, design and marketing of advanced consumer diagnostic products.

Their research centre is at the cutting edge of innovation and is fully engaged in the development of reliable diagnostic products to empower women on their reproductive journey. They are committed to answering the needs of their existing and future consumers, through a continuous flow of new and innovative products.