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Quality Manager

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Tewkesbury

On-site

GBP 40,000 - 45,000

Full time

30+ days ago

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Job summary

An established industry player is seeking a Quality Manager to uphold and enhance quality standards in a regulated manufacturing environment. This pivotal role involves managing Quality Management Systems (QMS) and ensuring compliance with ISO certifications, including ISO 9001 and ISO 13485. The ideal candidate will have substantial experience in quality assurance and auditing within sectors like medical devices or pharmaceuticals. You will lead quality audits, manage documentation processes, and address customer complaints effectively. Join a dynamic team where your expertise will drive continual improvement and excellence in quality assurance.

Qualifications

  • Experience in a regulated manufacturing environment is essential.
  • Knowledge of ISO standards, especially ISO 9001, is crucial.

Responsibilities

  • Implement and improve ISO certifications and manage QMS.
  • Conduct internal and external quality audits and ensure compliance.

Skills

ISO 9001
Internal Audits
External Audits
Quality Management Systems (QMS)
Problem Solving

Education

Engineering Degree
Experience in Regulated Environment

Job description

Job Description

Job Title: Quality Manager

Location: Tewkesbury

Salary: £40K - £45K

Job Type: Full time, though part time considered for the right candidate / Permanent

About Us:

Colt precision ltd are now recruiting for a Quality Manager on a permanent basis. This critical role is at the heart of ensuring quality and compliance, taking ownership of QA and QMS across our site. The role offers a competitive salary of £40,000-£45,000 plus benefits. This is a full-time position although we may consider a reduced hours contract for the right candidate.

About the role:

As a Quality Manager, you will play an integral role in maintaining the high standards of our customer requirements with a focus on implementing, maintaining, and improving ISO certifications. You'll be responsible for the Quality Management Systems (QMS), driving continual improvement in quality standards while also planning and implementing internal and external quality audits. You will ensure that all documentation is in place for raw materials, semi-finished goods, and finished goods to comply with agreed specifications, supporting the management in overseeing the safety of the laboratory and accuracy of documentation methods and calibrations. As Quality Manager, part of your responsibility is to support investigations into non-conforming products both internally and at suppliers' end, as well as dealing with customer complaints promptly and implementing corrective action processes.

Duties and Responsibilities:

  1. Implement, maintain and improve ISO 9001 and ISO 13485 certifications.
  2. Responsible for the Quality Management System (QMS).
  3. Plan, implement and drive internal and external quality audits.
  4. Ensure that all documentation is in place to ensure that raw material, semi-finished goods, and finished goods are compliant with agreed specifications.
  5. Responsible for team supervision, documentation methods, and calibration.
  6. Support investigation of non-conforming products (internal manufacturing and at supplier's), ensuring customer complaints are dealt with in a timely manner and implement corrective action processes.
  7. Provide escalation, weekly updates, and reports.
  8. Take personal responsibility for the notification and tracking of quality activities and related database entry/data accuracy.

About you:

The ideal candidate for the Quality Manager role will bring a wealth of experience from working in a manufacturing or production environment with a background within a regulated setting such as Med Device, Pharma, or aerospace. You will have a solid understanding and experience of ISO 9001, while knowledge of other standards such as ISO14001, ISO45001, and ISO13485 would also be advantageous. Your experience conducting internal and external audits will be crucial to your success in this role, so your application should demonstrate auditor training or qualifications.

  1. Engineering Degree or Proven experience.
  2. Experience of working in a regulated manufacturing/production environment.
  3. Knowledge and experience of ISO 9001.
  4. Experience of conducting internal and external audits.
  5. Experience of working with Medical devices is desirable.
  6. Knowledge of other standards such as ISO14001, ISO45001, and ISO13485 would be an advantage.

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