We design, develop and manufacture biomaterial scaffolds for use in regenerative medicine devices. The company is located at the Rutherford Appleton Laboratory campus in Harwell near Oxford, employs 8 people and has held ISO 13485 medical device quality certification since 2015. We wish to recruit a Quality Specialist to support the growth of our Contract Development and Manufacturing business. The individual will report to the CEO and work closely with an external Quality Consultant.

 

Main responsibilities:

  • Maintain the ISO 13485 Quality Management System (QMS);
  • Compile, assess and monitor ongoing quality tracking metrics to help drive efficiency and continual improvement;
  • Schedule and carry out routine quality control tests;
  • Design and amend quality control protocols and SOPs;
  • Support internal validation activities;
  • Assist with the administration of quality assurance procedures;
  • Compile Quality documents including Certificates of Analysis, technical files and batch records;
  • Assist line managers in implementing Health and Safety systems and procedures;
  • Assist in the investigation of internal and external non-conformances;
  • Maintain document control and ensure changes are documented and trained out.

Experience, Skills and Attributes

  • Educated to BSc in Science or Engineering;
  • At least 2 years’ experience working in a quality control environment, including design and validation of quality control assays, ideally in a medical related industry;
  • Experience with QMS ISO13485, FDA 21 CFR 820 and EU MDD 93/42/EEC. ISO 10993 experience desirable;
  • Excellent communication and interpersonal skills;
  • Practical experience of health and safety in a fast paced scientific, manufacturing and/or engineering environments;
  • Experience in delivering training;
  • PC-literate, able to present information coherently, accurately and persuasively.

Salary dependent upon experience, pension, 25 days holiday per year.

Please apply to info@electrospinning.co.uk by 17th November.