sharing the costs of sports activities
Pracodawca zakończył zbieranie zgłoszeń na tę ofertę
Aktualne oferty pracodawcyPracodawca zakończył zbieranie zgłoszeń na tę ofertę
Aktualne oferty pracodawcyMedical Quality Specialist
Flextronics Logistics
Łódź
Łódź, Łódź- offer expired a month ago
- contract of employment
- full-time
- specialist (Mid / Regular)
- full office work, hybrid work
- запрошуємо працівників з України

Your responsibilities
Assuring the conformance of all organization's regulatory and quality systems requirements.
Verify the proper implementation and effectiveness of the applicable Regulations, Standards, Policies, Directives and Procedures in the organization.
Provide support to any area that requires help to implement regulatory and quality requirements into their processes.
Develop training programs for internal users in subjects related to Regulations or Quality Systems.
Performs Quality System audits
Plan, execute and follow up any Area/Process Audit when required by the organization.
Create audit reports that identify any Non-Conformance or Opportunities for Improvement found during the audit process.
Stay up-to-date on New/Revised Regulations, Standards, Policies, Directives and Procedures
Attend in external audits and represent company in customers audits
Ensure performance is regularly reported and that appropriate and timely corrective actions are implemented
Our requirements
Technical University degree
3 years experience working in an medical environment, additional advantage knowledge FDA regulatory
Lead-Auditor-Qualification (internal and / or external) (ISO13485-2016)is an advantage
Experience using Statistics, Lean and Six Sigma Methodologies along with Measurement System Analysis, 8-D / CAPA / FMEA/ 5WHY etc.
Fluent English
Polish knowledge
A team player capable of independent work with strong communication
An excellent understanding and practical application of medical device quality system regulations, e.g. ISO 13485, ISO 14971 including implementation of same, additional advantage 21 CFR 820.
Additional advantage knowledge of the appropriate medical device regulations (21CFR), FDA law, Eu MDR (Eu Medical Device Regulation), other global laws and regulations and standards and related particular standards as applicable.
Understanding of the validation requirements for process, equipment and software and the conducting of the associated validations.
What we offer
Interesting and challenging job in an experienced and close-knit team
Substantive support in the process of adaptation
Participation in projects of international scope and cooperation with high-class specialists
Grant to study or learn foreign languages
Social package (private medical care and co-financing for sport card)
Group life insurance
Clear promotion criteria
Contract of employment
Benefits
private medical care
sharing the costs of foreign language classes
sharing the costs of professional training & courses
life insurance
flexible working time
integration events
corporate sports team
no dress code
coffee / tea
drinks
parking space for employees
extra social benefits
sharing the costs of holidays for kids
christmas gifts
employee referral program
charity initiatives
To support our extraordinary teams who build great products and contribute to our growth, we’re looking to add a Medical Quality Specialist located in Łódź, Poland.
Reporting to the Medical Quality Regulatory Manager, the Medical Quality Specialist role involves participation in the implementation of actions related to the quality of processes.
Flextronics Logistics
At Flex, we welcome people of all backgrounds. Our employees thrive here by living our values: we support each other as we strive to find a better way, we move fast with discipline and purpose, and we do the right thing always. Through a respectful, inclusive and collaborative culture, a career at Flex offers the opportunity to make a difference, invest in your career growth and join our purpose -- to make great products that create value and improve people’s lives.