Senior QA Manager

TN United Kingdom; Greater London; Hybrid; GBP 50,000 - 90,000; Full time

Job summary

An established industry player in medical equipment manufacturing is seeking a Senior Quality Assurance Manager to spearhead quality initiatives and ensure compliance with ISO standards. This dynamic role involves overseeing quality management systems, collaborating with leadership to set benchmarks, and driving improvements to meet ambitious growth targets. If you have a strong background in Quality Assurance within the medical device sector and are passionate about maintaining high standards, this opportunity offers a chance to make a significant impact in a forward-thinking organization. Embrace the challenge and help shape the future of patient care.

Qualifications

• 5+ years of experience in Quality Assurance Management in the medical device industry.
• Strong knowledge of ISO standards and regulatory processes.

Responsibilities

• Manage ISO:13485 accreditation and maintain quality standards.
• Collaborate with the Senior Leadership Team to improve quality management.

Skills

ISO:13485

ISO:9001

ISO:27001

GDP working practices

Quality Assurance Management

Regulatory processes and regulations

Communication skills

Problem-solving skills

Job description

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CPL are working with a leading Medical Equipment Manufacturing organisation with a growing workforce and expanding requirements for remote patient sampling, they require a Senior Quality Assurance Manager to join the team to achieve their ambitious growth in the coming years.

This position is based out of Croydon operating on a hybrid working model.

Responsibilities

Responsibility of the Management Representative for the ISO:13485 accreditation

Maintain accreditations for ISO:13485, ISO: 9001, ISO:14001, ISO:27001, and FSC

Oversee the business’ performance and activities to maintain GDP standards and maintain an MHRA WDA license

Collaborate with the Senior Leadership Team to set quality benchmarks, the effectiveness of the quality management system and improvements required

Identify and review Quality issues, develop proposals, and make decisions with input from the QA team

Promote and approve processes and procedures in accordance with industry standards and customer expectations

Competency requirements

Strong knowledge of ISO:13485, ISO:9001, ISO:27001

Knowledge of GDP working practices

Understanding of and ability to determine relevance of governmental regulatory processes and regulations.

5+ years of medical device industry experience, in Quality Assurance Management

Broad knowledge of ISO 13485:2016, US FDA, and European Medical Device Regulations (MDD, MDR, IVDD, IVDR)

Strong organization, communication, and problem-solving skills

Apply

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Overview

CPL are working with a leading Medical Equipment Manufacturing organisation with a growing workforce and expanding requirements for remote patient sampling, they require a Senior Quality Assurance Manager to join the team to achieve their ambitious growth in the coming years.

This position is based out of Croydon operating on a hybrid working model.

Responsibilities

Responsibility of the Management Representative for the ISO:13485 accreditation

Maintain accreditations for ISO:13485, ISO: 9001, ISO:14001, ISO:27001, and FSC

Oversee the business’ performance and activities to maintain GDP standards and maintain an MHRA WDA license

Collaborate with the Senior Leadership Team to set quality benchmarks, the effectiveness of the quality management system and improvements required

Identify and review Quality issues, develop proposals, and make decisions with input from the QA team

Promote and approve processes and procedures in accordance with industry standards and customer expectations

Competency requirements

Strong knowledge of ISO:13485, ISO:9001, ISO:27001

Knowledge of GDP working practices

Understanding of and ability to determine relevance of governmental regulatory processes and regulations.

5+ years of medical device industry experience, in Quality Assurance Management

Broad knowledge of ISO 13485:2016, US FDA, and European Medical Device Regulations (MDD, MDR, IVDD, IVDR)

Strong organization, communication, and problem-solving skills

Apply

Full name Email address Cover Message (optional) Upload CV Choose File Upload your CV and any other relevant file. Contact via SMS (optional) I would like to be contacted via SMS Privacy Policy I have read and agree to the Clinical Professionals Group Privacy Policy

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