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Quality and Compliance Manager

Michael Page Scotland
Job LocationEdinburgh
EducationNot Mentioned
Salary50,000 - 60,000 per annum
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent , full-time

Job Description

We are currently recruiting for a Quality and Compliance Manager for one of our clients in the Edinburgh/Dunfermline area who specialise in the manufacturer of medical devices.Client DetailsOur client has been established for over 30 years and pride themselves on offering complete customer care with their medical devices manufactured on site.Description

  • Responsible for ensuring the ongoing maintenance of a robust and compliant quality management system across the business thus assuring the consistency and quality of products, process and services through effective supplier management, goods-in inspectionand production oversight and support.
  • Deputise for Director of Quality.
  • Working with all elements of the business to provide oversight of ongoing Compliance Roadmap outlining new and updated medical devices regulations ensuring that the client compliance is maintained.
  • Assure adherence to quality systems so that 3rd party inspection expectations are met.
  • Assure procedures for medical device/adverse event handling and reporting to FDA/Competent Authority are effective in conjunction with the Director of QA and Senior Director of Regulatory Affairs
  • Assure recall procedures are effective globally.
  • Develop and support ongoing cross functional programme of supplier management alongside Supply Chain and Engineering functions.
  • Lead continuous improvement activities withing the QA production support function driving a culture of right first time.
ProfileBusiness Skills
  • Previous experience of people management (strong people management skills - able to identify, attract, develop and retain).
  • An ability to work within tight deadlines and manage time effectively.
  • Strong team player with a flexible attitude to work priorities.
  • Excellent written and verbal communication skills including delivering presentations/training.
  • Highly adaptable with the ability to work cross functionally, guiding the business in all aspects of Quality.
Technical skills
  • Knowledge of ISO 9001/13485 system is desirable however not essential
  • Knowledge of cGMP/Quality System Regulations is essential
  • Degree in sciences, life sciences, engineering or quality management or equivalent education gained through work experiences.
  • Excellent practical experience of quality assurance, ideally in a manufacturing environment.
  • Good awareness of FDA & MHRA systems and procedures.
  • Qualified internal auditor preferable.
  • Sound awareness of quality issues within a supply chain environment.
Job OfferSalary £50k-£60k + excellent benefitsOur client also offers a strong hybrid working from home model.

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