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Quality and Compliance Officer – Medical Devices

Employer
KINGS COLLEGE LONDON
Location
London (Greater) (GB)
Salary
£40,386 to £47,414 per annum, including London Weighting Allowance
Closing date
31 Aug 2023

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Job Details

Job description

This is an exciting opportunity for an experienced quality professional to support the design, development and manufacturing of innovative medical devices for first-in-patient clinical investigations.  

 

The post holder will be based in the School of Biomedical Engineering & Imaging Sciences, King's College London. Located within a hospital environment, our mission is to generate tangible clinical and commercial translation through our stimulating collaborations to achieve the unexpected, and advance research, innovation and teaching progress through our shared mission of engineering better health for patients worldwide. The Quality and Compliance Officer will support the operation of the new facility for the Manufacture of Active Implants and Surgical Instruments (MAISI) and work with research teams developing state-of-the-art medical technology, including surgical robotics, imaging software and AI, to follow the Medical Engineering Quality Management System (QMS) procedures. 

 

The individual will join a growing Quality Team and work with clinicians, staff and students in a clinical academic setting to ensure medical devices meet regulatory, quality and safety standards.  You will be required to work on implementing and maintaining key processes in the quality system and will be joining the team as the manufacturing facility is constructed and undergoes validation in 2023. 

 

The individual will report to the Manufacturing Quality Assurance Lead – Medical Devices, and work with all users of the QMS including production staff, research groups, and top management. The post holder will be required to ensure compliance and readiness of the quality system to ISO 13485 in preparation for certification. 

 

This post will be offered on  a fixed-term contract for 2 years 

This is a full-time post - 100% full time equivalent

 

Key responsibilities

•       Perform document control activities, including creating, distributing, modifying, storing and reviewing documents and records. Inform staff of the release of new documents and revisions.

•       Manage and retain accurate records of any reported deviations and violations.

•       Coordinate and manage completion of complaints, change control, non-conformance, corrective and preventive actions.

•       Assist with management of training records as required.

•       Schedule Management Review and Quality Meetings, ensuring outputs are recorded.

•       Reviewing and approving validation plans/protocols and reports.

•       Supporting the requestor, when required, in the processes associated with supplier planning for supplier approval. Conduct supplier evaluations.

•       Support cleanroom team with review and approval of commissioning, IQ, OQ, PQ, validation and operating documentation.

•       Perform QA product release and batch record review of sterile and non-sterile products.

•       Assist in inspection, approval and testing of incoming materials and components.

•       Review the monitoring and reporting of cleanroom environmental monitoring, product bioburden trends etc.

•       Participate in internal and external audits

•       Support the operation and implementation of an electronic QMS

•       Support manufacturing QC testing program

•       Initial review of documents and batch records

•       Ensure compliance of quality system and collate quality system metrics

•       Organise, deliver and participate in internal and external training sessions

 

The above list of responsibilities may not be exhaustive, and the post holder will be required to undertake such tasks and responsibilities as may reasonably be expected within the scope and grading of the post. 

 

Skills, knowledge, and experience

Essential criteria

1.       Degree or equivalent experience in engineering discipline (biomedical, electronic, mechanical, materials), quality, or related subject.

2.       Knowledge of quality system standards and regulation, e.g. ISO 13485, 21 CFR 820, AIMD, MDD and MDR.

3.       Experience in writing and reviewing quality system documentation including standard operating procedures, templates, forms and records, to ensure compliance with requirements.

4.       Knowledge / experience of good manufacturing practices and medical device or similar cleanroom manufacturing and operation.

5.       Experience of developing and implementing appropriate measures and tests of quality.

6.       Competence in use of QMS and IT tools, including MS Office, Sharepoint, MS Teams, Word, Excel and Outlook.

7.       Experience in document control and use of document management system.

8.       Attention to detail with excellent organisational, written, verbal communication skills and ability to troubleshoot.

9.       Ability to work collaboratively with different teams to agreed deadlines.

10.   To embrace the challenge of setting-up a new facility be flexible, open-minded and creative with innovative ideas and a can-do attitude to provide solutions to establish a compliant facility.

 

Desirable criteria

1.       Experience of monitoring and reporting of cleanroom environment, product bioburden trends, or endotoxin testing.

2.       Participation in audits.

3.       Experience of chairing meetings and taking formal minutes.

4.       Experience of QC testing

Company

King's College London is one of the top 20 universities in the world and among the oldest in England. King's has more than 27,600 students (of whom nearly 10,500 are graduate students) from some 150 countries worldwide, and some 6,800 staff.

King's has an outstanding reputation for world-class teaching and cutting-edge research. In the 2014 Research Excellence Framework (REF) King’s was ranked 6th nationally in the ‘power’ ranking, which takes into account both the quality and quantity of research activity, and 7th for quality according to Times Higher Education rankings. Eighty-four per cent of research at King’s was deemed ‘world-leading’ or ‘internationally excellent’ (3* and 4*). The university is in the top seven UK universities for research earnings and has an overall annual income of more than £684 million.

King's has a particularly distinguished reputation in the humanities, law, the sciences (including a wide range of health areas such as psychiatry, medicine, nursing and dentistry) and social sciences including international affairs. It has played a major role in many of the advances that have shaped modern life, such as the discovery of the structure of DNA and research that led to the development of radio, television, mobile phones and radar.

King's College London and Guy's and St Thomas', King's College Hospital and South London and Maudsley NHS Foundation Trusts are part of King's Health Partners. King's Health Partners Academic Health Sciences Centre (AHSC) is a pioneering global collaboration between one of the world's leading research-led universities and three of London's most successful NHS Foundation Trusts, including leading teaching hospitals and comprehensive mental health services. For more information, visit: www.kingshealthpartners.org.

King’s £600 million campaign, World questions|KING’s answers, has delivered huge global impact in areas where King’s has particular expertise. Philanthropic support has funded new research to save young lives at Evelina London Children’s Hospital; established the King’s Dickson Poon School of Law as a worldwide leader in transnational law; built a new Cancer Centre at Guy’s Hospital; allowed unique collaboration between leading neuroscientists to fast-track new treatments for Alzheimer’s, Parkinson’s, motor neurone disease, depression and schizophrenia at the new Maurice Wohl Clinical Neuroscience Institute; created the Cicely Saunders Institute: the first academic institution in the world dedicated to palliative care, and supported the King’s Sierra Leone Partnership in the Ebola crisis. Donations provide over 300 of the most promising students with scholarships and bursaries each year. More information about the campaign is available at www.kcl.ac.uk/kingsanswers.

Company info
Mini-site
KINGS COLLEGE LONDON
Telephone
+(44)02078365454
Location
STRAND
LONDON
WC2R 2LS
GB

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