JOIN OUR INNOVATIVE TEAM AT DOCTAP!

DocTap, a leading private GP service, is seeking an experienced ISO 15189 Quality Consultant to elevate our point of care laboratory services to the highest international standards.
We pride ourselves on delivering excellent clinical care, prioritising patient health needs, and providing affordable appointments in a caring environment. Our team of experienced clinicians is dedicated to ensuring the best outcomes for our patients.
We’ve recently introduced point-of-care testing to our services, revolutionising the way we deliver healthcare. This advancement allows us to provide results faster than ever before, significantly enhancing patient care and outcomes. Not only does this mean quicker diagnosis and treatment plans, but it also alleviates patient anxiety by reducing wait times. By integrating this innovative approach, we reaffirm our commitment to excellence and patient-centered care.

Why Join DocTap?

• Innovative Care: Step into a role where your contributions directly enhance our healthcare service, streamline patient experiences and improve outcomes.
• Commitment to Clinical Excellence: Be a cornerstone of our ambitious project to achieve ISO 15189 and POCT 22870 accreditation. Your expert insights will be vital in shaping the quality and precision of our services, ensuring we meet the highest international standards. This is your chance to make a significant impact in a forward-thinking environment dedicated to clinical excellence.

Role Responsibilities
In this pivotal role, you will be an expert advisor, leveraging your extensive knowledge of ISO 15189 to guide the Quality Manager through all aspects of the standard. This involves performing comprehensive evaluations to identify gaps in current systems against the ISO 15189:2022 and ISO 22870 requirements for point-of-care testing (POCT).
Enhancing the quality of documentation is key, allowing you to offer insights on creating effective standard operating procedures (SOPs), worksheet logs, audit procedures, risk assessments, and corrective and preventive action (CAPA) processes. It’s also crucial to facilitate learning and development by conducting training sessions and workshops to help the Quality Manager implement these standards effectively.
To ensure readiness for inspections, you will develop internal audit readiness by aligning all documentation with UKAS inspection criteria.
How will you achieve this?
You will achieve this over a contact period estimated at 3 months (with potential for extension with future site-openings and planned expansion of services provided.)

Summary Overview of required input

• Management Structure & Responsibilities
• Ensure clear definition of roles and responsibilities within the lab.
• Establish a quality management system (QMS) that aligns with both standards.
• Quality Management System (QMS)
• Review existing QMS documents for compliance with ISO 15189 and ISO 22870.
• Review Document procedures and processes thoroughly
• Personnel Competency
• Assess current training programs and compare them against ISO requirements.
• Implement a continuous professional development plan.
• Equipment & Calibration
• Check that all equipment is calibrated and maintained according to standards.
• Maintain records for equipment validation and performance checks.
• Laboratory Environment
• Evaluate the lab environment for safety, cleanliness, and controlled conditions.
• Ensure that the lab layout supports efficient workflow.
• Pre-analytical, Analytical, and Post-analytical Processes
• Review all phases of testing to ensure they meet quality standards.
• Standardise procedures for sample handling and testing.
• Document Control and Record Keeping
• Ensure all documents are controlled, current, and accessible.
• Implement a robust record-keeping system for traceability.
• Internal Audits and Management Reviews
• Review audit procedures. Plan and schedule regular internal audits.
• Use audit findings to drive continuous improvement.
• Risk Management and Improvement
• Identify potential risks in lab operations and develop mitigation strategies.
• Encourage a culture of continuous improvement.
• Customer Feedback and Complaint Handling
• Review process for collecting and addressing customer feedback.
• Analyse feedback to improve service quality.
• Review process for non-conformances, corrective and preventive actions and analyses

Required Skills & Experience

• Extensive hands-on experience with ISO 15189:2012 or 2022 implementation or accreditation - clinical scientist experience would be ideal
• Strong ability to train, coach, and mentor quality personnel.
• Deep understanding of QMS design, lab documentation structures, and audit preparation.
• Experience with UKAS inspections or similar accreditation bodies.
• Background in a regulated clinical, diagnostic, or medical laboratory environment.
• Excellent communication, interpersonal, and documentation review skills.
• ISO 15189 Internal Auditor or Lead Auditor certification is desirable.

Job Type: Contract role, Full time hours (37.5) over 12 week period reporting in to the CEO and Medical director
Salary: Competitive
Work location: London, mainly remote working with some scheduled on-site visits
Job Types: Full-time, Fixed term contract
Contract length: 3 months

Benefits:

• Flexitime
• Work from home

Application question(s):

• Do you have extensive hands-on experience with ISO 15189:2012 or 2022 implementation or accreditation?
• What is your salary expectation ?

Work authorisation:

• United Kingdom (required)

Work Location: Hybrid remote in London EC2N 2H

Please refer the Job description for details