Quality Engineer - Design Assurance, GET STAFFED ONLINE RECRUITMENT LIMITEDGuardian Jobs • Bedford, IN, US
Quality Engineer - Design Assurance, GET STAFFED ONLINE RECRUITMENT LIMITED
Guardian Jobs • Bedford, IN, US
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- serp_jobs.job_card.full_time
- serp_jobs.job_card.permanent
job_description.job_card.job_descriptionExperience in a medical device environment with knowledge of ISO 13485 Passion for quality and design assurance Excellent communication skills and ability to build effective relationships Knowledge of Software as a Medical Device is desirable Understanding of US FDA 21 CFR 820, EU IVD Directive, or MDD Directive is advantageous Competitive salary and bonus Hybrid working with flexibility 25 days paid leave plus bank holidays Company pension and private medical insurance Enhanced maternity / paternity pay Health and Wellbeing programs, life assurance, free parking, and more
Quality Engineer - Design Assurance, GET STAFFED ONLINE RECRUITMENT LIMITED
Join to apply for the Quality Engineer - Design Assurance, GET STAFFED ONLINE RECRUITMENT LIMITED role at Guardian Jobs
Position Overview
Location : Bedford, Hybrid
Contract : Full time, permanent
Salary : £35,000 - £40,000 + Benefits
About the Company
Our client is a world leader in research, design, and supply of advanced consumer diagnostic products, recognized globally for accurate home pregnancy and fertility tests. They are seeking a Quality Engineer - Design Assurance to join their team due to internal promotion.
Role Responsibilities
- Support compliance of innovation projects to standards and regulations
- Manage Quality activities related to Design Assurance, including documentation and device design change control
- Work across areas such as Concept Innovation, NPI, Transfer to Manufacturing, and Software as a Medical Device
- Perform general Quality Assurance duties to support Quality Objectives
- Ensure compliance with ISO 13485, EU In-Vitro Diagnostic Medical Device Regulation, US FDA 21 CFR Part 820, and other standards
Candidate Requirements
Benefits
Note : Applicants must have the right to work in the UK; sponsorship is not available for this role.
Additional Information
Our client values diversity and is an equal opportunity employer. They are committed to innovation and developing reliable diagnostic products to empower women in their reproductive journey.
J-18808-Ljbffr
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