Job Title:Quality Control Co-Ordinator
Job Title:Quality Control Co-ordinator
Primary Role:
- Work with the Quality Team to ensure that QC system requirements are effectively established and maintained
- To develop and manage Sphere’s in-house Quality Control activities;
- To develop the protocols employed to assess the quality and performance of incoming raw materials, intermediates and products as required.
- To ensure that only suitable material is released for subsequent manufacture and or sale, including release onto company ERP system
(Includinglabelling)
- To ensure that outgoing product meets specifications.
- To collaborate with other company members on Quality Control issues
- To co-ordinate the validation of Quality Control methodology and related software.
Other Roles:
- To finalise current test RD procedures and practices into the Quality System in compliance with ISO 13485 or other required standards.
- Co-ordinate the preparation and/or maintenance of computer programs for the compiling and analysis of QC data
- Co-ordinate the development, maintenance and review of QC charts
- Co-ordinate and track QC activities associated with the CAPA process, providing a QC resource for problem identification, resolution and continuous improvement
- Co-ordinate the development and presentation of the training program for QC related activities, developing training protocols and documentation requirements
- Assist in supporting onsite QMS, Notified body and customer audits
- Provide reports on QC activities as required
- Assist with other relevant activities or projects, as required
- To liaise with QA on quality issues;
- To contribute to product specifications;
- To contribute to performance and reliability protocols
Skills:
- Excellent numeric skills (proficient with Excel)
- High level of computer skills (Word, PowerPoint)
- Good communication skills
- Keen attention to detail and proven ability to perform experiments in an efficient and safe manner.
- Ability to develop and follow procedures in a repeatable manner and to a high standard.
- Ability to organise own work and that of others to meet deadlines.
Personal Attributes:
- Highly self motivated
- Well organised and detail-oriented
- Team-player, ability to work effectively within a multi-disciplinary team;
- Ability to motivate others;
- Self confident;
- Attention to detail;
- Open and honest;
- Able to work to tight deadlines.
Education:
- Science or Engineering degree or HND
Experience:
- Aminimum of Fouryears’ experience in a similar role, preferably within the medical device / pharmaceutical industry
- Experience of working within quality systems essential e.g. ISO 9001, 13485,GLP, GMP
- Experience of supporting ISO 13485 and FDA audits preferred but not essential.
- Experience as internal auditor preferred.
- Working with cross functional groups
FM:113 Issue 3 17/10/2014 Page 1 of1