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    Quality Engineer - United Kingdom - Lightcast Discovery Ltd

    Lightcast Discovery Ltd
    Lightcast Discovery Ltd United Kingdom

    2 weeks ago

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    Description

    About the role

    As Lightcast continues to grow from strength to strength, we are further expanding our Quality and Regulatory team and looking to appoint a Quality Engineer. Reporting into the Head of Quality and Regulatory, and working closely with our Development, Manufacturing and Assay teams, the successful candidate will be responsible for a wide range of QMS activities.

    You will be supporting the QMS Certification to ISO 9001 (ongoing scope changes and maintenance). You will also be responsible for ensuring development and operation activities of the ISO9001/ Pharma meet the requirements of relevant regulation, 21 CFR 820, 62304, 14971 and other applicable standards for an early-stage development and release of the platform to the market.

    The position also supports program management, development (Product/Software), Lab and Business operations through all phases of the Product/Software Lifecycle and operational quality.

    Your responsibilities will include

    • Being the Quality representative for the Product Development, Software development, Assay workflow and other operational activities.
    • Being the Quality representative for one or more departments providing QA expertise, identifying opportunities for QMS improvements, and leading the implementation of those improvements.
    • Developing, planning, conducting internal audit, and following on to closure of the audit non-conformances (Internal/external).
    • Supporting and overseeing internal calibration, incoming materials and supplier process.
    • Taking the lead in solving quality related problems within production and assay teams (ISO 15189 preferred).
    • Leading quality engineering activities for the introduction of new products lines from development to operations, inspection plan, production documentation and risk assessments.
    • Monitoring of quality KPI's and input to management review.
    • Coaching and supporting the writing of procedures, instructions, protocols, risk assessments and specification and carry out the relevant document management system updates.
    • Preparing and creating quality management system documents, work instruction and records.
    • Reviewing and approving development documents, change controls and other QMS system documents.
    • Safety is everyone responsibility. Other tasks as directed in line with company milestones and objectives.

    Requirements

    The successful candidate will have a proven background within Quality and Regulatory of electro/mechanical, medical/fluidics devices or related industries.

    We would expect you to have:

    • Knowledge and/or experience of working to ISO9001, FDA 21 CFR Part 820 and GMP. Some knowledge of 15189 would be useful.
    • Proven combined experience in Pharma, ISO 9001 operation environment.
    • Competent IT skills, Skilled in other Electronic QMS systems like document management systems, NC/CAPA, Complaints.
    • Ability to use problem-solving tools and methodologies.
    • Ability to influence internal and external parties to maximise success.
    • Self-starter with good communication skills and attention to detail.
    • Strong organisational, planning skills and time management with hands on approach.

    It would be advantageous for you to have:

    • Other Software systems like Jira/Jama/Confluence/Aligned Elements.
    • Working in GMP environment useful.
    • Experience in Quality support process like supplier control, change control, non-conformances, corrective, and preventive actions CAPA, deviation and complaint investigation and continuous improvement preferred.

    Lightcast Discovery offer competitive salaries and comprehensive benefits including:

    • 26 days holiday, plus Public Holidays
    • Flexible working hours
    • Pension contribution matched up to 7%
    • Private medical insurance
    • Income protection
    • Life insurance
    • Subsidised gym membership and weekly cross fit sessions
    • Access to Cycle to Work and Technology schemes
    • Enhanced family leave policies

    Here at Lightcast Discovery we have an informal, open work environment where collaboration and innovation are at the heart of what we do. We are based in West Cambridge, near excellent transport links and plenty of local amenities. We regularly gather as a team to hear about developments across functions and to share ideas. We enjoy social events and regular team lunches, promote career development and learning opportunities. It is an exciting time to join our revolutionary team as we push boundaries and continue to grow.

    #J-18808-Ljbffr
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