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Product Quality Engineer
Unomedical s.r.o.
Place of work
Priemyselný park 3, District Michalovce
Priemyselný park 3, District Michalovce
Contract type
full-time
full-time
Start date
by agreement
by agreement
Wage (gross)
by agreement
by agreement
Information about the position
Job description, responsibilities and duties
•Lead quality aspects of product development including supporting Design Control, test method validation and transfer,
specification review, development of Quality Control Plan, supporting process validation, developing and maintaining risk
management data and lead Hazard Analysis and Use/Design FMEA.
•Be a point of contact for potential design changes; support projects impacting the design, evaluate and determine the impact of
change, risk assessments and resources required and any product improvement.
•Support and lead investigation for Non-Conformance and investigations of root causes detected from Post-Market surveillance
activities with potential for field action.
•Support / lead / review correction and corrective action plans for efficacy reviews.
•Provide statistical guidance including sampling plans.
•Support change control & validation teams.
•Assure with plant QE’s links between Control Plans, Process Validation and Sampling, are aligned and documented.
•Understand and proactively identify areas of improvements, cost and complaint reduction.
specification review, development of Quality Control Plan, supporting process validation, developing and maintaining risk
management data and lead Hazard Analysis and Use/Design FMEA.
•Be a point of contact for potential design changes; support projects impacting the design, evaluate and determine the impact of
change, risk assessments and resources required and any product improvement.
•Support and lead investigation for Non-Conformance and investigations of root causes detected from Post-Market surveillance
activities with potential for field action.
•Support / lead / review correction and corrective action plans for efficacy reviews.
•Provide statistical guidance including sampling plans.
•Support change control & validation teams.
•Assure with plant QE’s links between Control Plans, Process Validation and Sampling, are aligned and documented.
•Understand and proactively identify areas of improvements, cost and complaint reduction.
Requirements for the employee
Candidates with education suit the position
University education (Master's degree)
Postgraduate (Doctorate)
Postgraduate (Doctorate)
Educational Specialization
Science or Engineering subject, or relevant area
Language skills
English - Upper intermediate (B2)
Other knowledge
Microsoft Outlook - Advanced
Personality requirements and skills
•Degree (or equivalent) in a Science or Engineering subject, or relevant area.
•Demonstrated knowledge of Regulatory and GXP Compliance requirements such as ISO 9001, ISO 13485, ISO 19011, QSR Part 820, MDD 93/42, GMP Parts 210 and 211.
•Good knowledge of Design Control, test methods, validation, environmental controls and change controls, statistics, root cause analysis, DoE and Continuous Improvement.
•Knowledge and experience of Risk Management Process and tools (e.g. FMEA, Process Mapping, Hazard Analysis and ISO 14971).
•Proficient user of Microsoft Office, Statistical tools (e.g. Minitab) and Project Management software (i.e. Microsoft Project).
•Demonstrated knowledge of Regulatory and GXP Compliance requirements such as ISO 9001, ISO 13485, ISO 19011, QSR Part 820, MDD 93/42, GMP Parts 210 and 211.
•Good knowledge of Design Control, test methods, validation, environmental controls and change controls, statistics, root cause analysis, DoE and Continuous Improvement.
•Knowledge and experience of Risk Management Process and tools (e.g. FMEA, Process Mapping, Hazard Analysis and ISO 14971).
•Proficient user of Microsoft Office, Statistical tools (e.g. Minitab) and Project Management software (i.e. Microsoft Project).
Advertiser
Brief description of the company
Pioneering trusted medical solutions to improve the lives we touch: Unomedical s.r.o. is a member of Convatec which is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in advanced wound care, ostomy care, continence care, and infusion care. With around 10,000 colleagues, we provide our products and services in almost 100 countries, united by a promise to be forever caring. Our solutions provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs. Group revenues in 2022 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more about Convatec, please visit http://www.convatecgroup.com
To find out more please visit https://careers.convatec.com - thanks for your interest!
To find out more please visit https://careers.convatec.com - thanks for your interest!
Number of employees
500-999 employees
Contact
ID: 2233865
Dátum zverejnenia: 24.8.2015
2015-08-24
lokalita: District Michalovce Pozícia: Quality Engineer Spoločnosť: Unomedical s.r.o.
Základná zložka mzdy (brutto) a ďalšie odmeny: by agreement