Senior QA Manager

Cpl Life Sciences; Greater London; Hybrid; GBP 60,000 - 75,000; Full time

Job summary

CPL is seeking a Senior Quality Assurance Manager for a leading Medical Equipment Manufacturing organization in Croydon with hybrid working. This role involves maintaining ISO accreditations, collaborating on quality benchmarks, and ensuring compliance with regulatory standards in a growing team.

Qualifications

• 5+ years of medical device industry experience in Quality Assurance Management.
• Broad knowledge of ISO 13485:2016, US FDA, and EU Medical Device Regulations.
• Understanding of governmental regulatory processes.

Responsibilities

• Responsible for ISO:13485 accreditation.
• Collaborate with the Senior Leadership Team to set quality benchmarks.
• Oversee business performance to maintain GDP standards.

Skills

Knowledge of ISO:13485

Knowledge of GDP working practices

Problem-solving skills

Strong organization

Communication 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

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

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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