Medical devices ivd Work, Jobs (with Salaries)

Quality Assurance (QA) Specialist
Mast Group Limited —Bootle
- From £35,000 a year
- Full-time
- Computer literacy
- Microsoft Office
- Presentation skills
- Life insurance
- Sick pay
Quick apply
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- Bachelor's degree
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Regulatory Affairs Specialist
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Manufacturing Engineer
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Principal Scientist, Clinical Research - Remote UK
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Quality Engineering Optimisation Manager
QuidelOrtho —Pencoed
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Quality Engineer - Computer Systems Validation
Oxford Nanopore Technologies —Oxford
- Full-time
- Computer Science
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Commercial Lead - Life Sciences
CambridgeDesign —Cambridge
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Quality Assurance (QA) Specialist

Mast Group Limited
Bootle

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Job details

Permanent | Full-time
From £35,000 a year
2 days ago

Benefits

Private medical insurance
Life insurance
Sick pay
On-site parking

Qualifications

Microbiology
Computer literacy
Regulatory reporting
Quality management
ISO 9001
Microsoft Office
Quality assurance
Presentation skills
Bachelor's degree
Organisational skills
Root cause analysis
Communication skills
ISO 13485

Full job description

Mast Group Ltd. are a world class manufacturer and supplier of diagnostic products for clinical, industrial and veterinary testing. As an independent company, since 1959, our commitment to maintaining integrity and customer satisfaction,* combined with innovation in in-vitro diagnostics, has resulted in improved clinical decisions and pathways. We recognise our responsibility to provide reliable*, fit for purpose in-vitro diagnostics in every community globally.

We are looking to recruit a highly skilled and conscientious Quality Assurance Specialist to join the team based at our site in Bootle. The job holder will be an integral part of the team, ensuring the effective compliance of quality standards across the business, ensuring professionalism in all that we do. The successful candidate should be willing to actively engage and contribute their technical knowledge, to aid quality assurance and compliance across the business providing effective guidance and advice in line with quality standards and regulatory requirements for the benefit of the mast portfolio of products.

THE ROLE

Identify and ensure compliance with ISO13485 and ISO9001standards, and regulations related to IVD medical devices products.
Ensure compliance across all product manufacturing, marketing and sales areas.
Development of Quality Assurance procedures.
Identify nonconformities and corrective/preventive actions.
Carry out effectiveness checks for corrective/preventive actions.
Cross departmental collaboration to enable resolution of quality issues.
Accurate QA document and record management and retention.
Working with complaints investigations from receipt to successful completion.
Work with R&D functions to ensure compilation, storage and accessibility of product technical documentation, in line with quality standards and regulatory requirements.
Work with other departments to provide advice and support in regulatory and quality assurance matters

In addition to the specified duties the Quality Assurance Specialist is expected to perform additional tasks that the QARA Manager/QARA Team Leader may require.

THE PERSON

Proven experience of understanding and working directly with ISO 13485 and a QMS environment.
Relevant associated experience in a similar field.
Excellent understanding and practical use of how a QMS operates
Knowledge of In-Vitro Device Regulation
Experience of preparing and presenting written reports and documentation.
Demonstrable experience of problem-solving techniques such as risk-based thinking, root cause analysis etc.
Excellent communication skills at all levels, both internally and externally
Organised, with a good attention to detail
Ability to work on own initiative and plan workload effectively
Computer literacy essential for Microsoft and other packages
Knowledge of diagnostic products and microbiology
Understanding of ISO 9001 or 17025 an advantage
Life sciences or related degree desirable but not essential

In addition to the specified duties the employee is expected to perform additional tasks when reasonably called upon to do so.

Job Types: Full-time, Permanent

Pay: From £35,000.00 per year

Benefits:

Life insurance
On-site parking
Private medical insurance
Sick pay

Application question(s):

What do you know about In-Vitro Device Regulations?
Are you authorised to work in the UK without the requirement for Visa sponsorship?
Do you have a life sciences or related degree?
Outline your experience of quality management systems such as ISO13485 ?
What experience do you have of a QMS environment?

Education:

Bachelor's (required)

Work authorisation:

United Kingdom (required)

Work Location: In person

Quick apply

Refine Your Search

medical devices ivd jobs

Quality Assurance (QA) Specialist

QA Associate

Regulatory Affairs Specialist

Supervisor R&D

Manufacturing Engineer

Product Development Lead - Diagnostics

Supplier Quality Manager

Quality Partner, Commercial (EMEA & LATAM)

Principal Scientist, Clinical Research - Remote UK

Quality Engineering Optimisation Manager

Quality Engineer - Computer Systems Validation

Commercial Lead - Life Sciences

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