Quality Officer - Medical Devices
Location: Newcastle Upon Tyne
Our client is one of the most exciting life sciences, tools and diagnostics companies to emerge from the UK in recent years. Due for commercialisation in 2018, their signature device, Q-POC™, is a low-cost, simple-to-use, portable diagnostic device for 10 – 20 minute diagnosis at the patient’s side. The robust device will identify the presence and strain of an infection, ensuring the right drug is prescribed first time, facilitating a more intelligent use of antibiotics. Further to this, globally distributed Q-POC™ devices will geotag and anonymise pathogen data, sending it to the cloud for real-time disease and drug resistance monitoring, and rapid detection and containment of pathogens.
Q-POC™ is ideally suited to help address the humanitarian health burden by offering gold-standard molecular diagnostics at a fraction of the price of traditional testing. Once the device has passed regulatory approval it will be available for highly multiplexed diagnostic and drug susceptibility testing for just a few dollars, in any setting globally.
About the job
The successful candidate would be responsible for developing, revising and implementing Quality procedures and policies for our client to facilitate relevant company certifications and Regulatory compliance as the company enters product development and commercialisation phases. This will include working toward ISO 13485:2016 certification and compliance with BS EN ISO 14971:2012. The position will report directly to the Head of Quality & Regulatory Affairs
Planning, undertaking and recording the validation of QMS-related software packages and supporting the software engineering team with production of compliant software within our medical device.
Key Roles & Responsibilities
Performing a combination, but not necessarily all, of the following duties:
• Involvement in the compilation and maintenance of Medical Device Files and Device Master Records in preparation for Regulatory submissions in various markets globally.
• Implementing systems that facilitate productivity, improve processes and guarantee efficacy. They will also be involved in and lead training sessions to ensure the understanding and compliance of all employees.
• Administering, preparing and conducting internal quality system audits and external vendor assurance audits as necessary.
• Maintenance of electronic Quality Management System, Q-Pulse including monitoring and progression of CAPA and audit actions.
• Active involvement in internal Health and Safety processes and procedures.
• Promotion the benefits of a quality system to all employees.
• Work within the Quality team to maintain focused, effective progression in line with Company Quality objectives.
• Effectively interact with Technical and Development teams to ensure research and development is performed in accordance with company procedures.
• Work with purchasing staff to establish Quality requirements from external suppliers.
• Ensure compliance with relevant national and international standards and legislation.
• Ensure policies and procedures are properly understood, carried out and evaluated and that modifications are investigated if necessary.
• Helping to train staff in Quality and Regulatory requirements and rules.
• Facilitate the continued work toward established goals, objectives, policies, procedures and systems pertaining to the QMS.
• Work to help ensure that Quality compliance objectives and targets are achieved.
• Consider the application of HSE standards, assist in the review and update of all SOP and safety documentation where required.
• Investigate relevant standards and establish clearly defined Quality methods for staff to apply.
• Define Quality procedures in conjunction with operating staff.
• Maintain controls and documentation procedures.
• Participate in the Company audit schedules for both internal and external Quality audits.
• Monitoring Quality indicators and helping to gather and track relevant data.
• Monitoring Health and Safety metrics and helping 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 when required.
• Perform other duties that may be required from time to time.
Experience, knowledge and requirements
• Experience of working with ISO 13485.
• A degree in Life Sciences is essential and experience of software validation.
• A highly motivated, organized, proactive and enthusiastic individual with a proven ability to work and motivate with utmost tact and diplomacy.
• Outstanding teamwork and ability to interact with external and internal partners on fast-paced projects.
• Ability to work full time within the UK without restriction.
• Experience working in the IVD industry.
• Good sense of humour and ability to adapt to a changing environment as the Company matures and moves from the R&D stage into commercialisation.
†Please apply below if you are interested.
The recruiter has stated that all applicants for this job should be able to prove that they are legally entitled to work in the UK. CY Partners Recruitment Ltd, trading as CY Partners is an Employment Business/Agency.
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