Medical 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
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Запрошуємо працівників з України
Роботодавець відкритий для працевлаштування громадян 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

  • sharing the costs of sports activities

  • 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.

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