Location: Rutherford Appleton Laboratories, Harwell, Oxford, UK
Start date: ASAP (recognising applicants may have notice periods)
Salary: £30-40K (Dependent upon experience)
Benefits: Pension scheme with 3% employer contribution
Holiday: 25 days per year, of which 3 must be taken around Christmas when site closed
Apply by: 31st October 2018
Apply to: email@example.com (attention of Ann Kramer)
The Electrospinning Company Ltd
We design, develop and manufacture materials, specifically nanofibre polymer scaffolds, which are used in tissue engineering/ regenerative medicine applications. We have a diverse range of client-led and internal R&D projects and operate to ISO 13485:2016 medical device quality standards. In October 2018, we are moving from the Rutherford Appleton Laboratory business incubator into brand new, purpose-built cleanroom facilities on the Harwell campus and wish to grow our team (currently 10 people).
We wish to recruit a Quality Manager to support the growth of our Contract Development and Manufacturing business. The individual will report to the CEO and will have access to support from an external Quality Consultant.
- Implement, disseminate and maintain QMS documentation and document control;
- Implement effective QMS processes in conjunction with operating staff;
- Maintain QMS processes such as audits (internal and external), supplier qualification, change control, non-conforming product and corrective and preventive action systems;
- Compile, assess and monitor ongoing quality tracking metrics to help drive efficiency and continual improvement;
- Act as the management representative for ISO 13485:2016;
- Schedule and carry out routine quality control tests;
- Support internal validation activities;
- 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;
Experience, Skills and Attributes
- Educated to BSc or equivalent 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 part 820 and EU MDD 93/42/EEC and Risk Management to EN ISO 14971;
- Excellent communication and interpersonal skills, in particular the communication of QA information to non-QA audiences;
- Knowledge of Health and Safety in the workplace is preferred;
- Proficient with standard software such as MS Office;
- Enthusiasm for quality assurance!
Unfortunately we are not able to obtain working visas for non-Europeans so you will need the right to work in the United Kingdom.