Software Quality Specialist

Employment type:Regular

Employment time:Full-time

Percentage of time the position involves travel:0%

Percentage of time the position allows for working off-site:0%

Job category:Computer and Mathematics

Job industry:Manufacturing - Other

Description

*CURRENT EMPLOYEES :

Job Description

For our office in Timisoara we are looking to hire a Software Quality Specialist who will be responsible to provide support during software validation projects as needed in Medical area.

We are looking for someone who demonstrates:

• Intense collaboration;
• Passionate customer focus;
• Thoughtful, fast, disciplined execution;
• Tenacious commitment to continuous improvement;
• Relentless drive to win.

Here is a glimpse of what you’ll do:

• Will coordinate and supervise the software validation team in order to reach project’s goals within the deadline and at the quality required;
• Understand software use functionality, work with standards/regulations pertaining software/computer system validation;
• Support the development of test cases, advice on test case outcomes, support report writing, and approve reports;
• Maintain Software Validation Master Plan up to date; Perform software validation trainings;
• Plan and monitor all deliverables together with software validation team, respecting clients deadlines;
• Write Software Validation Plans, Protocols and Summary Reports as needed;
• Communicate with corporate software validation team on use and validation of different software;
• Provide QMS guidance and support to software users and IT department on the change management process for software associated with medical devices; 
• Provide ongoing support and advice on software related medical device compliance aspects as needed.

Here is some of what you’ll need:

• University Degree (preferred in Electronics/ Telecommunication/Automation/ IT);
• Minimum 4 years’ experience in quality area and in Project Management;
• Quality standards knowledge ISO, ISO, 21 CFR, 21CFR, 21 CFR211 - would be a plus;
• Software Development Life Cycle knowledge;
• MS Office - Average level (Excel, PowerPoint, Word);
• English – Advanced level skills;
• Excellent communication and presentation skills; analytical thinking;
• Proactive attitude, able to work with minimum supervision;

Job Category

Flex does not accept unsolicited resumes from headhunters, recruitment agencies or fee based recruitment services. Flex is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. Flex does not discriminate in employment opportunities or practices 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. Flex provides reasonable accommodation so that qualified applicants with a disability may participate in the selection process. Please advise us of any accommodations you request to express interest in a position by e-mailing: . Please state your request for assistance in your message. Only reasonable accommodation requests related to applying for a specific position within Flex will be reviewed at the e-mail address. Flex will contact you if it is determined that your background is a match to the required skills required for this position. Thank you for considering a career with Flex.