Sr. Quality Engineer

Sr. Quality Engineer (Randstad Contingent Worker)

This role will be fully remote and can be based anywhere in the US.  However, the work hours must align to EST time zone.  

In this role, you will have the opportunity to:

The Sr. Quality Engineer for Early Development is accountable for oversight of quality and risk management throughout the pre-productization development phase. This role ensures that products/prototypes are developed in accordance with applicable standards & regulations to facilitate transfer into (clinical) studies or further development and commercialization.  In this role you will be responsible for supporting one or more Research Portfolios for risk, ensuring key initiatives are executed and providing independent oversight to applicable design control elements.

You will be responsible for:

• Acts as single point of contact for R&D teams to ensure appropriate QMS processes are identified and implemented within the project, including identifying applicable deliverables and tailoring as appropriate 
• Identifies Quality / Regulatory requirements based on scope of development activities
• Provide effective oversight of the execution of early design and risk management activities, including assisting teams in creation of Risk Management deliverables and reviewing or approving documentation
• Collaborate with Quality Engineering Functional Leader to drive improvements and alignments on quality engineering discipline across the cluster
• Provides leadership in assessing Quality Engineering related needs of various programs/sites.  Including prioritization based on risk/benefits.
• Makes meaningful contributions to the team in combining the Agile methodology with the Quality System requirements
• Ensures Quality is embedded within the organization by acting as a champion of best practices and by escalating quality related concerns
• Collects and reports on Quality related key performance indicators
• Communicate with Q&R both within Research as well as in the business to align expectations and escalate when needed to the appropriate level in case non-compliances are not solved.
• Provides guidance on key design inputs like usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability and costs
• Provides hands-on guidance in the creation of Design deliverables required by the Quality System
• Act as a point of contact for multiple projects responsible to ensure that hardware design meets quality and compliance standards for every milestone

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

• 5+ years of Quality Engineering experience in a regulated environment preferably within the Medical Device space
• Masters’ degree, or equivalent, ideally in a related field such as Engineering or Computer Science or Bachelor’s degree with more than 5 years experience
• Experience in producing and guiding others to complete Quality Engineering Documents. Able to develop & administers quality related project plans and schedules.
• Experience in performing timely, quality engineering tasks like:
• Assessing quality plans and product designs
• Reviewing test and other performance data
• Analyses of risk inputs and mitigations
• Leading root cause analysis and quality problem solving.
• Mentor other team members on quality related projects or issues.
• Familiarity with hardware, embedded software and stand-alone software quality engineering principles
• Works on issues of diverse scope where analysis of situation or data requires evaluation of a variety of factors, including an understanding of current business trends.  Follows processes and operational policies in selecting methods and techniques for obtaining solutions.
• Experience in early product development or pre-manufacturing activities

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.