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Quality Engineer
OXYMAT - Slovakia, s.r.o.
Place of work
Vaďovce
Vaďovce
Contract type
full-time
full-time
Start date
ASAP
ASAP
Wage (gross)
1 600 EUR/monthFinal basic salary can be adjusted according to individual skills and experience of selected candidate
1 600 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
• Ensuring that products are in compliance with PED 2014/68/EC (Pressure equipment directive) and related standards
• Ensuring that products are in compliance with MDD 93/42/EC (Medical device directive) respective with the new regulation MDR 2017/45/EC (Medical device regulation) and related standards
• Maintenance and regular update technical files according to PED, MDD respectively MDR (General Safety and Performance Requirements checklist, Clinical evaluation etc.)
• Follow up on new and revised standards and regulatory
• Managing and conducting internal and external audits (audits of Notify Body, audits at the suppliers)
• Incoming inspection of the material
• Final inspection of the product – standard and projects (visual and documentation)
• Control of internal nonconformities, customer complaints
• Active participation on certification and customers audits
• Ensuring that products are in compliance with MDD 93/42/EC (Medical device directive) respective with the new regulation MDR 2017/45/EC (Medical device regulation) and related standards
• Maintenance and regular update technical files according to PED, MDD respectively MDR (General Safety and Performance Requirements checklist, Clinical evaluation etc.)
• Follow up on new and revised standards and regulatory
• Managing and conducting internal and external audits (audits of Notify Body, audits at the suppliers)
• Incoming inspection of the material
• Final inspection of the product – standard and projects (visual and documentation)
• Control of internal nonconformities, customer complaints
• Active participation on certification and customers audits
Employee perks, benefits
• Incentive wage
• Professional training and career opportunities
• Social benefits, team building activities, workshops
• Young and dynamic team of colleagues
• 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 (Master's degree)
Educational Specialization
Quality management, Technical, Engineering of quality production
Language skills
English - Upper intermediate (B2)
Other knowledge
Microsoft Outlook - Advanced
Microsoft Excel - Advanced
Microsoft Word - Advanced
Microsoft Excel - Advanced
Microsoft Word - Advanced
Driving licence
B
Personality requirements and skills
- working experiences in the quality in the production company
- knowledge of quality management - standards ISO 9001 respectively ISO 13485
- Experience /knowledge of the MDD 93/42/EC (Medical device directive) 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
- Experience /knowledge of the MDD 93/42/EC (Medical device directive) 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: 4041073
Dátum zverejnenia: 3.3.2021
2021-03-03
lokalita: Vaďovce Pozícia: ISO Specialist, Quality Engineer Spoločnosť: OXYMAT - Slovakia, s.r.o.
Základná zložka mzdy (brutto): 1 600 EUR/month