Product Quality Engineer

Unomedical s.r.o.

Place of work
Priemyselný park 3, Michalovce
Contract type
full-time
Start date
by agreement
Salary offered (gross)
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.

Information about the selection process

Only the candidates who meet our requirements will be invited to the interview.

Requirements for the employee

Candidates with education suit the position

University education (Master's degree)
Postgraduate (Doctorate)

Educational Specialization

Science or Engineering subject, or relevant area

Language skills

English - Upper intermediate (B2)

Computer skills - user

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).

Advertiser

Brief description of the company

ConvaTec is a global medical products and technologies company, with leading market positions in ostomy care, wound therapeutics, continence and critical care, and infusion devices. Our products provide a range of clinical and economic benefits, including infection prevention, protection of at-risk skin, improved patient outcomes and reduced total cost of care.

Number of employees

500-999 employees

Company address

Unomedical, s. r. o.
Priemyselný park 3
071 01 Michalovce
http://www.unomedical.com

Contact

Contact person: Eva Gazdičová
Tel.: 056/6815125
E-mail: send CV
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ID: 2731964   Dátum zverejnenia: 22.9.2016