Exciting Medical Devices Development company seeks a highly self-motivated and enthusiastic Quality Control Officer to be responsible for helping to maintain and improve the Quality Management System by employing excellent attention to detail, managing time efficiently and effectively and bringing outstanding teamwork skills to the role.
Duties may include:
- Check incoming material documentation/certification
- Physically inspect incoming materials
- Support the Engineering and Assay teams in testing of incoming materials and assisting with non-routine analyses.
- Perform investigations where required
- Perform finished product testing according to test methods and product specifications including qPCR on standard laboratory instrumentation including BioRad CFX96 and Qiagen Rotor-Gene Q
- Help to develop, validate and the perform finished product test methods to facilitate QC testing of instruments and consumables
- Liaise with the Purchasing and Sales teams to ensure all materials released in time for use
- Help to generate and maintain incoming material specifications
- Work with the Operations team to suitably oversee controlled temperature shipments of samples and products
- Input into supplier complaints where required
- Ensure all documentation for incoming materials is completed promptly and made available by PDF for batch review
- Assist with management of outsourcing raw material identity testing
- Raise QMS documentation for Deviations, Change Control, Supplier Complaint where relevant for incoming material QC
- Assist with management of laboratory supplies
- Perform all activities in a safe manner with strict adherence to company guidelines
- Work within the Quality team to maintain focused, effective progression in line with Company Quality objectives.
- Support other members of the Quality team by providing training and mentoring on areas of expertise.
- Effectively interact with Technical, Development, Manufacturing, Operations, Sales and Marketing and Planning teams.
- Ensure policies and procedures are properly understood, carried out and evaluated and that modifications are investigated if necessary.
- Help to train staff in Quality Control requirements.
- Investigate relevant standards and establish clearly defined Quality methods for staff to apply.
- Define Quality procedures in conjunction with R&D and Operations staff.
- Maintain process controls and documentation procedures and identify areas for improvement and efficiency.
- Support product design review and change control systems.
- Participate in the Company audit schedules for both internal and external Quality audits.
- Monitor Quality indicators and helping to gather and track relevant data.
- Identify relevant Quality-related training needs and delivering training.
- QA/QC review of contractor documentation relating to validation and verification activities as well as device manufacture records.
Skills and experience:
- Good attention to detail
- Proficiency in Microsoft software packages
- Proven experience in a controlled environment of document checking and review
- Ability to prioritise and time manage
- Life science or Chemistry qualifications
- A highly motivated, organized, proactive and enthusiastic individual with a proven ability to work with tact and diplomacy.
- A minimum of 2 years' experience in working within a Quality Management System, with some specific experience of working with medical devices.
- Experience of working with ISO 13485
- Quality Control
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