Job description
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.
Job Summary
In our Milan Design Center, in Italy, we develop for the medical market.
For our expanding team, we are looking for a Quality Assurance Engineer.
The QA Engineer will be responsible for ensuring that all processes conform to internal quality system requirements (design control, in particular) and applicable international standards and are properly applied to projects in order to achieve coordinated results from all the areas involved.
What a typical day looks like:
- Guide design team in conformance to the international standards (e.g. ISO 14971, ISO 13485, 21 CFR Part 820) applicable to product development
- Serve as lead and coach in the implementation of design control and risk management requirements per above standards
- Work within the design team to ensure that standard operative procedures are correctly used and maintained during the product development
- Ensure that project data and technical documents related to product development process are managed according to document and change control procedure
- Ensure the configuration control of the medical device Bill of Material and its transfer to the manufacturing sites (through Agile PLM)
- Prepare and maintain the Design History File
- Record and fill in relevant documents for QA
- Supporting customers in quality assurance activities
- Participates in ISO Certification and surveillance audits and customer audits
The experience we’re looking to add to our team:
- Quality Assurance experience
- Fluent English and Italian both in written and spoken form
We consider the following experience as a plus:
- Graduate in Computer Science, or equivalent combination of education and experience
- Broad theoretical understanding and practical knowledge of SW Quality Assurance - SW configuration processes/techniques in Product Development Process
JV34
Job Category
Design, Process & Technology Engineering
Required Skills:
Optional Skills:
Flex is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. We celebrate diversity and do not discriminate based on: age, race, religion, color, sex, national origin, marital status, sexual orientation, gender identity, veteran status, disability, pregnancy status, or any other status protected by law. We're happy to provide reasonable accommodations to those with a disability for assistance in the recruitment process. Please advise us of any accommodations you may need by e-mailing:
accessibility@flex.com
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