Software Quality Assurance Engineer

Software Quality Assurance Engineer (Randstad Contingent Worker)

This position will be fully remote and can be home-based from anywhere in the US.  

In this role, you will have the opportunity to:

Provide software quality engineering support in design and development of medical device products. Facilitate the application of software design controls in product development and sustaining changes. 

You will be responsible for:

• Ensure software development and V&V processes meet quality and regulatory requirements of FDA and ISO

• Provide ongoing software quality engineering support throughout the product software life cycle by participating in Software development reviews, code reviews and formal software technical reviews

• Review new and modified product designs for quality characteristics, testability and traceable to product requirements.

• Review verification and validation test plans. Oversee testing and analysis for standards and product requirements compliance.

• Review Design History Files and Technical Files for conformance to applicable requirements

• Assist, when appropriate with internal and supplier audits.

• Provide management with status updates on assigned responsibilities and goals and escalate issues in a timely fashion

• Contribute to software life cycle process improvements

• Responsible for validating Non-Product Systems Software

• Create all required documents for Non-Product Systems Software

• Provide support on Non-Product Systems Software for various groups within the business

To succeed in this role, you should have the following skills and experience:

BS in Software related disciple or equivalent work experience.

3-5 years of software quality engineering experience or equivalence.

• Experience with test methods and standards for the design, verification, and validation of medical device products with emphasis around software development/testing.

• Understanding of Object-Oriented Programming

• Experience with analyzing data from SQL databases and writing SQL queries

• Understand the processes and intent of all aspects of the QMS related to Design Controls

• In-depth knowledge of and auditing experience to the 21CFR820, ISO 13485, IEC62304 and the Medical Device Directive.

• Skilled in test plan development and root cause/failure analysis.

• Good verbal (including presentation) and written communication skills, especially technical report writing.

• Ability to effectively work on project teams.

Preferred Skill Set:

• Familiarity with regulatory requirements e.g. IEC 62304, ISO 13485, 21 CFR Part 11, GAMP, 21 CFR 820 & ISO 14971.

• Experience in risk evaluation techniques, such as DFMEA & Product Risk Assessment.

• ASQ CQE, CSQE certification desirable, but not essential.

• National Instruments TestStand, LabVIEW knowledge and experience highly desirable

• Experience with Software Reliability is desirable

You will be a part of:

An organization that believes what you do every day can contribute to the innovative health technologies and solutions we develop that make a positive impact on billions of people every year. Including you. Because you will find when you work at Philips that your professional and personal lives often intersect in unexpected and fulfilling ways. It is our mission to improve people’s lives through meaningful innovation and we want you to play a central role in this by leading teams, driving projects, thinking strategically and inspiring colleagues from all over the world.

In return, we offer you:

Philips welcomes you to a challenging, innovative environment with great opportunities for you to explore and grow.

Quality is on the top of Philips leadership agenda and that means you have the unique opportunity to come in and have a recognized voice to drive and witness exciting, transformational changes. You will be empowered to drive high quality, groundbreaking innovations with a globally recognized, premium brand behind you. And when you are successful in this role you will have an array of diverse career opportunities open to you – across different functional areas, product lines, business groups and/or geographies. That is a commitment Philips Quality Leadership team has made and stands by.

Why work on a project at Philips?

If you’re looking for meaningful work and a chance to tackle complex challenges, broaden your skills and expertise and become an even more sought after professional, you’ll find all that and more with project work at Philips.

The Randstad companies are responsible for finding talent to provide services at Philips. If you are selected to provide services for Philips, you will be employed by Randstad and will not be an employee of Philips.