Hart Biologicals - Technical Scientist

Permanent, Full-time 37.5hrs p/w
£24,000 to £25,000 per annum
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Hart Biologicals is engaged in the research, development, manufacture, sale and marketing of a range of "in-vitro" diagnostic products for use in the detection, prevention, and monitoring of a number of medical conditions related to haemostasis and platelet function. The company provides innovative and quality medical products to meet the needs of an ever-changing healthcare field. Hart Biologicals employs 46 people and is located in the Northeast of England in Hartlepool

Duties & Responsibilities

Role is based within Hart’s Technical Department and an office is shared with the scientist team. Work is primarily based within the Technical Laboratory. The role focuses on maintaining & creation of product design history and technical files per the company ISO 13485 certification requirements. You will undertake technical investigations to support customers as well as dealing with customer queries. Complete development projects to update the product portfolio and design transfer of novel reagent formulations to a final production state.
 

• Perform Technical transfer of new products into Hart Biologicals.
• Perform practical laboratory tasks for product design/technical files and for investigation of technical issues or customer complaints/enquiries with formal test reports.
• Create and maintain Device Technical Files (IVDD/IVDR).
• Support Risk Management Process.
• Support Post Market Surveillance Process.
• Facilitate and record Customer Feedback.
• Review and report Real Time Stability Data.
• Create Device Master Records.
• Participate in Design and Process Validation.
• Manufacture EQA Samples.
• Observe confidentiality at all times.
• Contribute to positive environment within Technical Department.
• Implement and maintain good laboratory housekeeping.
• Work efficiently both independently and as part of a team.
• Report project status to supervisor/management.
• Support and train fellow team members/colleagues/placement students as and when required.
• Follow laboratory equipment use and maintenance procedures.
• Adhere to and maintain Health & Safety/COSHH Requirements.
• Draft documents for Quality Management System.
• Adhere and adapt to quality and regulatory updates.
• Liaise regularly with other departments to ensure the company maintains its high-quality standards.
• Undertake any other reasonable tasks as directed by Management.

Qualifications/Experience

Bachelor’s Degree (BSc), Bachelor of Technology (BTech) and/or previous experience in a similar role

A working knowledge of Haemostasis would be an advantage as well as an understanding of ISO13485 requirements and technical documentation.

An accountable, reliable, and trustworthy individual is required who can contribute to a small team environment.

This role will suit someone who would like to build some experience working in the healthcare sector in which the company operates and has an interest in In-Vitro Diagnostics.
Computer skills – word processing/presentation/spreadsheets.

Able to use initiative and manage tasks to meet defined time scales.

Additional Benefits

Company operates on a flexible working time system.
Company Healthcare Scheme.

Applications to be sent to: 
HR Department (CV & covering letter)
 
As a member of the Equality Register, Hart Biologicals is an equal opportunities employer and welcomes applications from all communities.
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