Contamac Ltd are looking to recruit a Quality Specialist / Engineer, who will work as part of the Quality Assurance Team to ensure that we meet our regulatory, compliance and strategic targets. Based in Saffron Walden, Essex, over three sites.
Quality Specialist / Engineer
- Support the Quality Assurance functions of R&D and Operations.
- Conduct equipment qualifications and software and process validations.
- Proactive improvement of operational processes.
- Performing internal audits to ISO 13485.
- Raising CAPA / deviations process for internal and external events.
- Manage equipment calibrations on site, internal and external.
- Support discussions with customers and regulators.
- Develop and maintain parts of the Quality Management System.
- Support supplier, customer and regulatory audits.
- Contribute to risk assessment activities.
- Perform statistical analysis of QA, production and R&D data and present findings.
- Write, review and amend SOP’s and other technical documentation.
- Work openly and effectively with all levels of the organisation, promoting a team approach and improving the quality of Contamac products and processes.
- Support the QA department with any other projects and investigations as required.
Skills and Experience:
- Minimum of 1-3 years in a medical device / pharma or manufacturing environment.
- Experience of working to ISO 13485 or cGxP would be beneficial.
- Must have a good level of computer literacy, familiar with Microsoft Word and Excel.
Contamac is the world’s largest supplier of contact and intraocular lens materials. A major global provider of biocompatible materials for implantable and medical applications to the ophthalmic industry. We are a double Queen's Award for Enterprise Winner, the first in 2012 for International Trade and then for Innovation in 2016.
Permanent, full-time, 37.5 hours pw, 23 days holiday + statutory days, pension scheme (5% company contribution), life assurance (4 x salary), Perkbox.