Peter Wardenski Email & Phone Number

Feldbrunnen-St. Niklaus, So, Ch

Switzerland

• Maintaining Quality Management System (QMS) in compliance with ISO 9001:2015; ISO 13485:2016; and MDSAP requirements.• Responsible for the European and US Quality and Sterility Assurance activities. Working in crossfunctional teams: Product Development (PD), Supplier Quality, Manufacturing, Marketing, RA,Compliance. Support applied research and development initiatives.• Managing and supporting new and existing projects (e.g. Spine, Trauma CMF, Power Tools, Neuro).• Review, establish, maintain and develop procedure tools and methodologies to cover all Quality and Sterility Assurance programs.• Interface with Regulatory Authorities during on-site inspections - planning, conduct report and follow up on QMS audit in accordance with ISO 13485. Submitting Tech Files for MDR certification - working closely with notified bodies and ensure that regulatory requirements are met.• Conducting and coordinating Cleaning, Chemical / Thermal Disinfection, V-PRO/STERRAD and Steam Sterilisation validations, IFU creation process.• Ensures compliance to MDR (previously MDD) requirements, ISO 13485, ISO 14971, ISO 9001 and FDA (QSR) regulations.• EN ISO 15883, EN ISO 17665, EN ISO 17664), AAMI standards/reports (e.g. AAMI TIR 12 and 30) and other guidance documents as required.• Develop, validate and evaluate cleaning, disinfection and sterilization (Gamma, Ethylene Oxide, Gas Plasma and Moist Heat) processes for new and existing products.• Implement and harmonize QA reprocessing strategies, practices and procedures.• Investigate non-conformities, completing deviation, CAPAs, Change Controls, OBS related to sterilization and contamination.• Perform regular internal auditing of product development and provide external audit support (e.g. MDSAP audit).

Poland

Based in FMCG company. • Leading and managing production personnel “make & pack” (group of approx. 25 machine operators, mechanics, electronics engineers). • Ensure production processes (ISO, Quality, Productivity, 5S, FIFO, Kanban, Gemba and other procedures) are followed consistently. Perform additional GMP, QUIP, 5S and pre-requisite checks assigned.• Keeping and continuously checking production documentation (e.g. specifications, reports, complaint protocols) and supervise changes.• Continuous improvement through the search and implementation of solutions leading to increasing work efficiency, product quality and reducing production costs and reducing waste. Ensure that production capacity is maximised at all times.• Notify and stop shipping as needs to prevent product being contaminated (e.g. tobacco) or wrong material has been used (e.g. filters, packages).• Support production in the development of effectiveness and the implementation of corrective actions.• Ensure that priority workloads are managed effectively to meet customer needs and contractual agreements.• Utilize decision making skills to reject/hold product.

Leeds, United Kingdom

Decontamination Facility manufacturing and reprocessing medical equipment, surgical instruments and supplies.• Leading and managing production personnel (approx. 60 CSSD technicians) across all departments (Wash Room, Packing Room, Sterile Department and Logistic). • Ensure that production capacity is always maximised, supporting the Site Operations Manager in ensuring first class service for users and patients exceeding contractual standards. • Incorporating Safety, Quality and Cost. Educate, coach and audit as appropriate such that the culture is aligned with the sterilisation process requirements. Ensure that production processes are followed consistently and compliance with the Standards, Procedures and Work instructions. • Ensuring continued compliance with all requirements of the MHRA and the Medical Devices Directive 93/42/EEC; maintenance of a fully accredited Quality Management System (ISO 13485). • Working closely and liaising with all key stakeholders, drive effective continuous improvement and lean activities in all operational aspects of the facility. Ensure that priority workloads are managed effectively. Organising transport for clean / dirty medical equipment and reporting delivery times of medical devices in accordance with strict delivery schedules to meet required turnaround times (IMS system). • Ensure a suitable standard of commercial awareness is maintained amongst all employees within the facility. Set and manage performance targets and clear deliverables for all direct reports.• Establishing a robust junior management team throughout off all the shifts.• Forming, developing and maintaining excellent relationships with prospective customers. Implement and cascade effectively the delivery of corporate strategy, and the facility business plan.• Reporting non – conformities through the established routes and documented procedures. • Validation of the Cleaning and Sterilization Processes used for Medical Instruments

Leeds, United Kingdom

• Supervising production personnel (approx. 20 CSSD technicians) across all departments (Wash Room, Packing Room and Sterile Department). Supervise technician for correctly packing, washing and preparing of all equipment and instruments for wrapping and sterilization. • Provides instruction to staff on Sterile Services requirements, e.g. delivery, turnaround times and quality issues.• Determines appropriate Sterile Services procedure and assess quality of Sterile Services packs before release and distribution. Plans and adjusts staff workload to meet user requirements.• Operates autoclave and other Sterile Services equipment and machines. Implements quality standards for Decontamination Facility and promotes procedural changes for own working area.• Supervise sterile processing and provides practical training to ensure prescribed quality of service. Responsible for recording and monitoring equipment testing and quality assurance checks.• Undertake audits or surveys as necessary for own and team work, works within Decontamination Facility procedures and guidelines. • Operating and testing (daily and weekly; bi’s test, protein test, bowie & dick, leak test, air detector, conductivity etc.) washers disinfectors, sterilizers, high vacuum cleaners and another sterilisation equipment.• Performs and participates in decontamination, cleaning, assembling, packaging, scanning, sterilization, storage and distribution of reusable surgical instrumentation and equipment. Performs other duties as assigned or required.• Initiating, planning, managing and controlling some small project such a new internal strategy for company.• Maintaining cleanliness and hygiene of work environment to improve the service quality.ISO Quality Standards and Guidance related to Medical Devices.

Leeds, United Kingdom

• Performs and participates in decontamination, cleaning, assembling, packaging, scanning, sterilization, storage and distribution of reusable surgical instrumentation and equipment. Performs other duties as assigned or required.• Operating and testing (daily and weekly) washers disinfectors, sterilizers, high vacuum cleaners and other sterilisation equipment. Processing the sterilization cycle which has been selected to deliver less lethality at a fraction of the routine cycle exposure time, as compared to the cycle which will be used for routine processing.• Checking the condition of instruments and medical devices according to the accredited QA system.• Assembling and packaging of trays, sets and supplementary items in accordance with instrument count sheets. • Reporting missing, damaged, defective or non – compliant devices and processes.Packaging and labelling of prepared sets for sterilisation process in line with documented procedures. • Loading and unloading of medical devices in accordance with quality procedures and manufacturers recommendations in washer disinfectors and sterilisers. • To ensure that all instruments and sets are effectively decontaminated prior to being made available for use in operating theatres, clinics etc.• Checking sterilized goods and their process documentation.

Poznan, Greater Poland District, Poland

• Design and delivery of automatic measurement (quality control) systems for individual orders based on electronic instrumentation and interfaces. Assess new developments or innovations to see if they are workable. Prepare technical plans using computer aided engineering and design software.• Calibration, validation of a wide range of instruments for electrical, temperature and humidity measurements. • Temperature and humidity mapping perform measurements of temperature and humidity distribution in facilities like warehouses, clean rooms, hospitals, cold rooms, climatic chambers, production rooms, laboratories.• Estimate manufacturing and labour costs and project timescales and analyse data. Make sure that projects meet safety regulations. Plan and oversee inspection and maintenance schedules.

Master'S Degree, Journalism And Social Communications

National Diploma, Electronics Engineering And Computer Science

Bachelor'S Degree, Journalism And Social Communications