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Quality Manager
OXYMAT - Slovakia, s.r.o.
Place of work
Vaďovce
Vaďovce
Contract type
full-time
full-time
Start date
ASAP
ASAP
Wage (gross)
2 700 EUR/monthFinal basic salary can be adjusted according to individual skills and experience of selected candidate
2 700 EUR/monthFinal basic salary can be adjusted according to individual skills and experience of selected candidate
Information about the position
Job description, responsibilities and duties
• Implementing, maintaining and improving Integrated management system in accordance with the requirements of ISO 9001, ISO 13485 and ISO 14001
• Control and evaluation of Quality objectives, Environmental objectives, targets and Programs
• Ensuring that products are in compliance with PED 2014/68/EC (Pressure Equipment Directive), MDR 2017/745 EC (Medical Device Regulation)
• Follow-up on new or revised regulatory requirements and standard within relevant standards and guidelines
• Managing and conducting internal, supplier and external audits
• Coordinating and initiating Quality, Environmental & Safety management activities
• Control, support and development of procedures for quality control in production
• Conduct internal training in the Integrated Management System and develop knowledge in the organization regarding Quality, Environment and Safety
• Non-conformance, corrective and preventive action management
• Final product inspection and product documentation control
• Report to the top management on the performance of the Quality management system and Environmental management system for review
• The technical documentation and the EU declaration of conformity are drawn up and kept up to date
• Planning, establishing, documenting, implementing, maintaining and updating a post-market surveillance system and Clinical evaluation in accordance with MDR
• Reporting obligations e.g., reporting of serious incidents and field safety corrective actions, trend reporting, analysis of serious incidents and field safety corrective actions, analysis of vigilance data etc.
• Communication with NOBO, COBO
• PRRC according to MDR
• Complaints register handling, responsible for regular meetings of compliance committee, reporting and follow up.
• Control and evaluation of Quality objectives, Environmental objectives, targets and Programs
• Ensuring that products are in compliance with PED 2014/68/EC (Pressure Equipment Directive), MDR 2017/745 EC (Medical Device Regulation)
• Follow-up on new or revised regulatory requirements and standard within relevant standards and guidelines
• Managing and conducting internal, supplier and external audits
• Coordinating and initiating Quality, Environmental & Safety management activities
• Control, support and development of procedures for quality control in production
• Conduct internal training in the Integrated Management System and develop knowledge in the organization regarding Quality, Environment and Safety
• Non-conformance, corrective and preventive action management
• Final product inspection and product documentation control
• Report to the top management on the performance of the Quality management system and Environmental management system for review
• The technical documentation and the EU declaration of conformity are drawn up and kept up to date
• Planning, establishing, documenting, implementing, maintaining and updating a post-market surveillance system and Clinical evaluation in accordance with MDR
• Reporting obligations e.g., reporting of serious incidents and field safety corrective actions, trend reporting, analysis of serious incidents and field safety corrective actions, analysis of vigilance data etc.
• Communication with NOBO, COBO
• PRRC according to MDR
• Complaints register handling, responsible for regular meetings of compliance committee, reporting and follow up.
Employee perks, benefits
A challenging, modern and rewarding full-time position in a dynamic international and employee friendly company on the move
• Incentive wage
• Professional training and career opportunities
• Social benefits, team building activities, workshops
• Young and dynamic team of colleagues
• Incentive wage
• Professional training and career opportunities
• Social benefits, team building activities, workshops
• Young and dynamic team of colleagues
Requirements for the employee
Candidates with education suit the position
University education (Bachelor's degree)
University education (Master's degree)
University education (Master's degree)
Educational Specialization
Quality management, Technical, Engineering of quality production
Language skills
English - Advanced (C1)
Other knowledge
Microsoft Word - Advanced
Microsoft Excel - Advanced
Microsoft PowerPoint - Advanced
Microsoft Outlook - Advanced
Microsoft Excel - Advanced
Microsoft PowerPoint - Advanced
Microsoft Outlook - Advanced
Driving licence
B
Experience in the position/sector
Quality
Number of years of experience
3
Personality requirements and skills
- Engineering background and well documented relevant international Quality management experience
- Knowledge of quality management - standards ISO 9001 respectively ISO 13485, ISO 14001
- Experience /knowledge of the MDR 2017/745EC (Medical device regulation) is a clear advantage
- Experience /knowledge of the PED 2014/68/EC (Pressure equipment directive) is a clear advantage
- Experience /knowledge of risk analysis FMEA is a clear advantage
- Pro-active approach to solving problems, independence, responsibility, communication skills, flexibility, teamwork
- Active communication with other departments in the field of quality management
- Knowledge of quality management - standards ISO 9001 respectively ISO 13485, ISO 14001
- Experience /knowledge of the MDR 2017/745EC (Medical device regulation) is a clear advantage
- Experience /knowledge of the PED 2014/68/EC (Pressure equipment directive) is a clear advantage
- Experience /knowledge of risk analysis FMEA is a clear advantage
- Pro-active approach to solving problems, independence, responsibility, communication skills, flexibility, teamwork
- Active communication with other departments in the field of quality management
Advertiser
Brief description of the company
OXYMAT A/S was acquired by Atlas Copco and will be part of the Industrial Air division within the Compressor Technique business area. The Compressor Technique business area provides solutions for compressed air: industrial compressors, gas and process compressors and expanders, air and gas treatment equipment and air management systems.
OXYMAT – headquartered in Denmark (HQ) and Slovakia, is the world's leading supplier of advanced PSA generator systems in Europe with 40 years of experience in the design, construction and manufacture of high quality oxygen and nitrogen generators according to specific customer needs and process specifications.
Our business is growing and we are modernizing and strengthening our organization. We are a modern company that is friendly to employees and the environment, and we are pleased to offer the most powerful and technologically advanced solutions in the world.
OXYMAT – headquartered in Denmark (HQ) and Slovakia, is the world's leading supplier of advanced PSA generator systems in Europe with 40 years of experience in the design, construction and manufacture of high quality oxygen and nitrogen generators according to specific customer needs and process specifications.
Our business is growing and we are modernizing and strengthening our organization. We are a modern company that is friendly to employees and the environment, and we are pleased to offer the most powerful and technologically advanced solutions in the world.
Number of employees
50-99 employees
ID: 4525437
Dátum zverejnenia: 23.2.2023
2023-02-23
lokalita: Vaďovce Pozícia: Quality Engineer, Quality Inspector, Quality Manager Spoločnosť: OXYMAT - Slovakia, s.r.o.
Základná zložka mzdy (brutto): 2 700 EUR/month