As Production Service Manager, you will provide senior operational leadership across the full sterile services production cycle, ensuring full compliance with regulatory and quality standards including HTM 01-01 and ISO 13485. You will be accountable for maintaining complete device and set traceability at all stages of production, delivering against agreed Service Level Agreements and Key Performance Indicators, and ensuring staff competencies are established, maintained, and regularly reviewed. The role includes responsibility for maintaining robust assurance and governance arrangements, supporting board‑level assurance in line with NHS Estates Technical Bulletin (NETB/2024/1), and leading continuous improvement across production services. You will directly manage Supervisors, Technicians, and Apprentice Decontamination Technicians, fostering high performance, engagement, and compliance. You will build and sustain effective working relationships with theatres, clinical services, and kitting and carting teams, contributing to incident management, audit readiness, and overall service governance. With a strong focus on production efficiency, quality, and people management, you will ensure items are processed safely and on time, in line with the Quality Management System. As a senior management team member, you will also provide cross‑cover and operational support as required to maintain service continuity and deliver departmental objectives.
Responsibilities
* Direct daily production activities across washroom, IAP, sterilisation, cooling, release, storage and dispatch to ensure alignment with demand and SLA/turnaround objectives; proactively manage capacity, staffing and machine availability.
* Maintain comprehensive traceability of devices and sets at all stages using departmental information systems; rigorously uphold traceability protocols and recall procedures.
* Execute contingency and business continuity strategies during downtime and coordinate effective communication with kitting, carting, theatres and clinical stakeholders.
* Oversee daily and weekly production planning, coordinating staffing, equipment and workflows across washroom, inspection/assembly/packing (IAP), sterilisation and dispatch to consistently achieve turnaround targets and right‑first‑time quality standards.
* Monitor and control production KPIs – including sets processed, rework, failed loads, equipment utilisation and backlog – and implement corrective actions as necessary.
* Schedule downtime, maintenance and validation periods in collaboration with AP(D)/CP(D) and engineering teams to minimise service disruptions; initiate business continuity procedures when required.
* Ensure proper segregation and traceability from receipt through dispatch utilising the department's information and track‑and‑trace systems.
* Support the operation of the Quality Management System (ISO 13485), including SOPs, records and controlled documents.
* Ensure compliance with HTM 01‑01, MHRA requirements and internal governance.
* Coordinate external audits and inspections, escalating issues as needed and ensuring management oversight.
* Contribute to internal audit schedules and quality assurance testing, address non‑conformances and oversee production practices in line with relevant standards and manufacturer IFUs.
* Manage daily/weekly equipment checks, environmental monitoring and take corrective action when necessary.
* Prepare for audits and certification visits, coordinate CAPA responses and keep accurate, compliant records.
* Manage Supervisors, Team Leaders, Technicians and production staff, including recruitment, induction, rostering, appraisals, performance and conduct.
* Support the local competency framework; ensure training logs, re‑assessment and CPD comply with IDSc and AHCS standards.
* Promote a culture of learning, psychological safety and continuous improvement.
* Set and monitor key performance indicators such as instrument/set turnaround times, defects, failed loads, complaints, audit actions, capacity utilisation and downtime.
* Produce monthly reports to track and evaluate department performance.
* Ensure the integrity of the department information system, managing non‑conformance, tracking locations, monitoring machine status and maintaining product recall readiness.
* Utilise the decontamination IT system to manage workflow, generate performance reports, handle non‑conformance issues and track sets/assets.
* Lead investigations of incidents and non‑conformance reports, determine root causes, implement corrective or preventive actions, escalate clinical incidents as needed and update risk register entries.
* Participate in and contribute to the Decontamination Safety Group (DSG), ensuring board‑level awareness and Trust‑wide assurance of safety issues.
* Foster a positive safety culture by keeping risk assessments up‑to‑date – including those for COSHH and manual handling – and ensuring relevant controls are implemented, such as enforcement of PPE and hygiene protocols.
* Direct or support incident reporting and investigation processes, conduct trend analyses, disseminate learning outcomes and coordinate product holds, recalls and clinical incident responses with theatres and infection prevention/control teams.
* Maintain effective document management practices and ensure compliance with standard operating procedures and permits‑to‑work requirements.
* Manage delegated budget areas (consumables, test devices, PPE); contribute to budget setting, procurement and cost improvement plans; ensure safe use/maintenance oversight of complex equipment.
* Maintain inventory levels for detergents, wraps, indicators and spare parts; evaluate new products and support procurement processes.
* Serve as the principal production contact for Oxford Kitting and Carting, theatres and other stakeholders; facilitate service reviews, customer feedback processes and drive continuous improvement initiatives (Lean methodology, flow optimisation, capacity planning).
* Develop policies with the Quality Manager and implement service modifications extending beyond individual areas, ensuring alignment with NETB/2024/1 and Trust strategy.
* Act as the primary liaison for Oxford Kitting and Carting, theatres and clinics regarding production status, constraints and recovery plans; chair or participate in stakeholder meetings and service reviews.
* Collaborate with scheduling teams, Oxford Kitting and Carting and theatre staff to coordinate instrument set availability with planned activities; oversee management of loan/set repairs, maintain vendor communication and ensure compliance with decontamination certification and traceability protocols.
* Lead and contribute to Continuous Improvement projects (Lean, Six Sigma, 5S) aimed at optimising workflow, reducing variation and rework and enhancing staff experience.
* Support business case development, capacity modelling and future service design – including integration of new technologies such as robotics and minimally invasive instruments and infrastructure upgrades.
Qualifications
* Degree or equivalent experience in healthcare science/management or a relevant technical discipline.
* IDSc Chartered Member (or ability to achieve within 12 months).
* AHCS Practitioner registration (or eligibility/commitment within 12 months, per competency framework).
* Evidence of HTM “User” course (or completion within 6 months).
Desirable Criteria
* Postgraduate qualification in Medical Device, Significant decontamination production experience, including supervision/leadership of teams across washroom, IAP and sterilisation.
* Proven delivery of service‑level performance in a sterile services environment, or equivalent environment.
* Managing non‑conformances, investigations, CAPA and audit preparation.
* Rostering and resource planning in a 24/7 or extended‑hours service.
* Cross‑site service management.
* Leading or experience in external certification audits (ISO 13485).
* Business case development and procurement support.
* Excellent communication and influencing skills with clinical stakeholders.
* Able to work under pressure, prioritise and make sound decisions.
* Commitment to staff development, CPD and just culture.
* Coaching/mentoring accreditation.
* Flexible to support shifts, weekends and bank holidays as service requires.
* Physically able to undertake manual handling of instrument sets with appropriate aids.
* Prepared to work in controlled environments with heat, humidity, noise and wearing PPE.
* In‑depth knowledge of HTM 01‑01, HBN13, ISO 13485 and manufacturer IFUs.
* Proficient use of decontamination track‑and‑trace systems and production reporting.
* Understanding of Spaulding classification and infection prevention principles.
* Strong analytical skills; able to interpret technical/quality data and equipment cycle results.
* Familiarity with robotics/minimally invasive instrument decontamination.
* Data visualisation/reporting skills (e.g. Excel, Power BI).
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