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Senior Quality Engineer
Świętego Mikołaja 19, Stare Miasto, Wrocław
Wygasła: 29.04.2024
full-time
umowa o pracę
kontrakt B2B
full office work
hybrid work
senior specialist (Senior)
Obowiązki:
Create and maintain quality management system procedures to support regulatory and quality compliance
Monitor, analyze, and improve the effectiveness of the quality management system
Develop corrective actions, solutions, and improvements
Support the D&D processes and ensure the requirements of specifications, standards and regulations are complied
Provide regulatory advice and guidance throughout the complete product lifecycle: Requirements, Design, Verification & Validation, Commercialization and Maintenance
Collaborate with S3 Connected Health teams and customers to develop and implement regulatory strategies and pathways for medical devices
Conduct internal audits and ensure timely follow through on resolution of related audit findings
Support S3 Connected Health certification (e.g., ISO 13485), customer and other regulatory audits
Participate in the evaluation and approval of S3 Connected Health suppliers
Create and maintain quality management system procedures to support regulatory and quality compliance
Monitor, analyze, and improve the effectiveness of the quality management system
Develop corrective actions, solutions, and improvements
Support the D&D processes and ensure the requirements of specifications, standards and regulations are complied
Provide regulatory advice and guidance throughout the complete product lifecycle: Requirements, Design, Verification & Validation, Commercialization and Maintenance
Collaborate with S3 Connected Health teams and customers to develop and implement regulatory strategies and pathways for medical devices
Conduct internal audits and ensure timely follow through on resolution of related audit findings
Support S3 Connected Health certification (e.g., ISO 13485), customer and other regulatory audits
Participate in the evaluation and approval of S3 Connected Health suppliers
Create and maintain quality management system procedures to support regulatory and quality compliance
Monitor, analyze, and improve the effectiveness of the quality management system
Develop corrective actions, solutions, and improvements
Support the D&D processes and ensure the requirements of specifications, standards and regulations are complied
Provide regulatory advice and guidance throughout the complete product lifecycle: Requirements, Design, Verification & Validation, Commercialization and Maintenance
Collaborate with S3 Connected Health teams and customers to develop and implement regulatory strategies and pathways for medical devices
Conduct internal audits and ensure timely follow through on resolution of related audit findings
Support S3 Connected Health certification (e.g., ISO 13485), customer and other regulatory audits
Participate in the evaluation and approval of S3 Connected Health suppliers
Create and maintain quality management system procedures to support regulatory and quality compliance
Monitor, analyze, and improve the effectiveness of the quality management system
Develop corrective actions, solutions, and improvements
Support the D&D processes and ensure the requirements of specifications, standards and regulations are complied
Provide regulatory advice and guidance throughout the complete product lifecycle: Requirements, Design, Verification & Validation, Commercialization and Maintenance
Collaborate with S3 Connected Health teams and customers to develop and implement regulatory strategies and pathways for medical devices
Conduct internal audits and ensure timely follow through on resolution of related audit findings
Support S3 Connected Health certification (e.g., ISO 13485), customer and other regulatory audits
Participate in the evaluation and approval of S3 Connected Health suppliers
Create and maintain quality management system procedures to support regulatory and quality compliance
Monitor, analyze and improve effectiveness of quality management system
Develop corrective actions, solutions, and improvements
Support the D&D processes and ensure the requirements of specifications, standards and regulations are complied
Provide regulatory advice and guidance throughout the complete product lifecycle: Requirements, Design, Verification & Validation, Commercialization and Maintenance
Collaborate with S3 Connected Health teams and customers to develop and implement regulatory strategies and pathways for medical devices
Conduct internal audits and ensure timely follow through on resolution of related audit findings
Support S3 Connected Health certification (e.g. ISO 13485), customer and other regulatory audits
Participate in the evaluation and approval of S3 Connected Health suppliers
Provide quality and regulatory related trainings
Ability to demonstrate the process behind the thinking
Create and maintain quality management system procedures to support regulatory and quality compliance
Monitor, analyze, and improve the effectiveness of the quality management system
Develop corrective actions, solutions, and improvements
Support the D&D processes and ensure the requirements of specifications, standards and regulations are complied
Provide regulatory advice and guidance throughout the complete product lifecycle: Requirements, Design, Verification & Validation, Commercialization and Maintenance
Collaborate with S3 Connected Health teams and customers to develop and implement regulatory strategies and pathways for medical devices
Conduct internal audits and ensure timely follow through on resolution of related audit findings
Support S3 Connected Health certification (e.g., ISO 13485), customer and other regulatory audits
Participate in the evaluation and approval of S3 Connected Health suppliers
Running the reception and dealing with day-to-day queries connected with general administration
Receiving company guests
Processing post, faxes, and email
Ordering all stationery supplies, courier services, and taxis
Arranging lunches for company guests and employees when required
Ensuring that office equipment is maintained properly
Contact and cooperation with company suppliers
Manage special occasion delivers such as flowers, cards, gifts
Managing the administration of a centralized business travel function (flights, accommodation, car rental) for Organisation employees worldwide
Managing the administration of Numara FootPrints, a system used for submitting travel requests by employees, tracking, and coordinating their travel process
Providing travel and accommodation alternatives, both cost and routing, for employees
Updating staff on travel/security updates as required
Maintenance of the Organisation’s travel standard operating procedures
Provide on-call support for employees traveling on company business
Assisting with various HR or Finance department administrative tasks as required
Maintenance activities: monitoring of production environment of customers or own products
Based on the available tools, scripts, and manuals, you will be accountable for deployments of new product versions, installation of updates, investigation of issues, and configuration changes
Support activities: interaction with customers, implementation of customer requests, interaction with development teams and preparation of usage reports
Running the reception and dealing with day-to-day queries connected with general administration
Receiving company guests
Processing post, faxes, and email
Ordering all stationery supplies, courier services and taxis
Arranging lunches for company guests and employees when required
Ensuring that office equipment is maintained properly
Contact and co-operation with company suppliers
Manage special occasion delivers such as flowers, cards, gifts
Managing the administration of a centralised business travel function (flights, accommodation, car rental) for Organisation employees worldwide
Managing the administration of Numara FootPrints, a system used for submitting travel requests by employees, tracking, and coordinating their travel process
Providing travel and accommodation alternatives, both cost and routing for employees
Updating staff on travel/security updates as required
Maintenance of the Organisation’s travel standard operating procedures
Provide on-call support for employees travelling on company business
Assisting with various HR or Finance department administrative tasks as required
Support, guide, and consult managers by leading them through all people processes
First contact for people by being responsive and solution-oriented for all kinds of people cases, being an advisor in labor regulations and compensations from on- to offboarding
Driving the local recruitment and selection process, including job analysis, interviewing, contract administration, and new employee induction
Contract management and administration for local sub-contractors
Administration and support of the compensation and benefits programme, including the provision of payroll inputs to Finance, is the point of contact for all pension, life assurance, and income protection-related issues, including renewals
Continuous improvement of people processes and policies
Maintaining a positive employee relations environment, including grievance and disciplinary handling
Ensuring employee engagement and retention by embedding Company values, relevant initiatives, and planning
Support competency modelling and job architecture activities
Generating and monitoring HR indicators, including annual leave, sickness, and headcount