Principal Eng, Quality Assurance
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Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
This is whereyour work makes a difference.
At Baxter we believe every personregardless of who they are or where they are fromdeserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today tomorrow and beyond.
Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together our community is driven by a culture of courage trust and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations and we hold each other accountable for delivering exceptional results.
Here you will find more than just a jobyou will find purpose and pride.
Job Description: -
This Principal Engineer Quality Assurance position falls within a growing team for Software person will work as a member of one or more cross-functional product development teams by being engaged in newproduct development and/ or sustaining products covering emerging technologies such as Digital Health Health SoftwareSoftware as a Medical Device (SaMD) and Clinical Decision Support (CDS). This individual will serve as a qualityrepresentative on the software project team and will work closely with the Core Team role is responsible for ensuring that each project is developed and released meeting customer expectations and in compliance with Baxters software lifecycle management policies and procedures. This Principal Engineer will work closely with product engineering to ensure robust requirements successful design development verification and validation testing design transfer and change control addition this individual will provide support to product software sustaining engineering and support the creation of regulatory submission documentation.
Qualifications: -
Bachelors degree in engineering or computer science with a minimum 10 years of experience in a highly regulated industry such as FDA DoD aerospace or telecom with a thorough understanding of the regulations standards Software Development Life Cycle (SDLC) and quality management systems.
Experience in assessing and developing procedure to meet Digital Health regulatory requirements and guidances.
Experience with FDA inspections. ISO/ Notified Body audits is a plus.
Experience in the application of design controls and compliance requirements in accordance with 21 CFR Part 820 803 & 806 IEC 62304 ISO 13485 ISO 14971 EU MDR 21st Century Cures Act NIST Cybersecurity framework FDA pre and post market cybersecurity guidance AGILE SDLC for the development of SaMD/CDS and Health Software products.
Professional certification such as ASQ IEEE Six Sigma LEAN manufacturing or achievement of certification. ASQ CSQE preferred.
Strong communication and leadership skills.
Strong results driven project management skills.
Excellent problem-solving skills and the ability to teach others.
Capable of clearly presenting and justifying quality position and requirements to management.
Hands-on Experience on Software development is added Advantage.
Equal Employment Opportunity
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race color religion gender national origin age sexual orientation gender identity or expression protected veteran status disability/handicap status or any other legally protected characteristic.
Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If because of a medical condition or disability you need a reasonable accommodation for any part of the application or interview process please click on the link here and let us know the nature of your request along with your contact information.
Recruitment Fraud Notice
Baxter has discovered incidents of employment scams where fraudulent parties pose as Baxter employees recruiters or other agents and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself review our Recruitment Fraud Notice.
Required Experience:
Staff IC
Key Skills
- Test Cases
- SQL
- Quality Assurance
- Agile
- TFS
- Jira
- Software Testing
- Test Automation
- Cucumber
- QA/QC
- SDLC
- Selenium
About Company
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected ... View more
