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26.09.2018 JOB

Quality Manager


In this business critical role the Quality Assurance Manager will be responsible for ensuring that all aspects of quality policy and procedures are promoted, adhered to monitored and measured. They will ensure our products and services meet the established standards of quality including reliability, usability and performance. They will ensure that NoxBox Ltd remains complaint with ISO 9001- 13485 standards and relevant Medical Device Regulations, working with our parent company Praxair on product compliance.

 

The role will also cover on-site Health and Safety management, implementing best practice SH&E policy and procedure locally and ensuring all employees comply.

 

Core duties

 

This position will work closely with the US based team in Praxair Inc to ensure:

  • Compliance with Medical Device Regulations
  • Management of CE marking files
  • Management of FDA 510k / PMA files
  • Management of NRTL (UL/MET etc) files and ongoing compliance
  • RoHS/WEEE/REACH
  • Regulatory testing submissions (60601/62304/62366)
  • Device vigilance and competent authority reporting (MHRA)
  • Risk management (new and ongoing) to ISO 14971
  • Technical file/DMR management / Validation

 

At a local level the incumbent will be expected to conduct QA final acceptance testing for all new releases, take the lead for all internal and external audits, take control of history files, records and documentation, conduct risk assessments and mini internal audits for the NOxBOX team and manage non-conformance to quality standards.

 

Person Specification

 

Educated to at least degree level you will have a keen eye for detail as well as being a completer-finisher; you will be comfortable identifying corrective and preventative actions on all quality concerns. You will be an able decision maker, who can engage and align business stakeholders on change management process, re-validation activities and best practice approaches.

 

Finding out why things have gone wrong will make you tick; you will thrive in understanding root cause issues, investigations and manufacturing deviations. You will use your knowledge as subject matter expert to report findings back to the business and implement the agreed recommendations for change.

 

Key Skills & Experience

 

  • Responsible for continual improvement activities to enhance the quality system, such as 5S, Kaizen lean methods
  • Develop training to build quality awareness within the team
  • Be focused on quality systems and regulations and keep working safe
  • Commercial awareness
  • Understanding technical information
  • Knowledge of automated Quality Management Systems (I. e Master Control System)
  • Must have a minimum of 5 years’ experience in Quality Engineering/Manufacturing
  • Must have previously worked on Medical Products
  • Ideally be trained in ISO 9001 & 13485, at a minimum have working knowledge of
  • Degree in Engineering Discipline

 

 

Salary: £38,000 – £48,000  DOE

 

Employment type: Full time, permanent

 

Other benefits inc: 25 days’ holiday, private health care, pension, flexible working

 

Please send your CV with your application to recruitment_uk@praxair.com