Data Analyst - Quality Engineering

In this role, you will have the opportunity to:

The Data Analyst - Quality Engineering will be assigned to R&D and post market surveillance teams during the design life cycle and will support data driven strategies for the operations, postmarked surveillance and quality extended teams. the analyst will interact with cross-functional teams to help define business needs and scope projects. This position will be accountable for building metrics to develop insights to drive continuous process improvements using advanced data analytic methodologies.

You will be responsible for:

• Work with cross functional groups such as New Product Development and Sustaining Engineering to ensure Quality problems have been identified and contained.

• Prepare information for Quality Management Reviews and Operational Reviews such as: trend charts, Pareto Analysis, etc., as required on complaint data.

• Create dashboards and metrics to monitor data quality

• Analyze and extract meaning from large data sets with SQL

• Write quality-checking automation

• Write sample ETL code in SQL to pilot potential production features

• Plan and lead discussions on metric evaluation to help product stakeholders make decisions

• Check and validate versions of big data through automation

• Coordinate testing efforts with the development team

• Create process documentation outlining analysis strategies for the Post Market Team

• Evaluation of complaint information received from clinical environments, such as device failure mode, manufacturing documentation review, labeling and instructions for use review.

• Follow up on Implementation of corrective and preventive actions.

• Assist the Research and Development department to verify that; modifications to the manufacturing processes and/or product design do not affect product suitability for its intended use.

• Performs other duties as needed to ensure compliance with relevant FDA QSRs, EU MDR and other ISO regulations.

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

EDUCATION:

• B.S. degree in an Business, Statistics, Computer Science, Engineering, Data, Analytics, or a related technical field or equivalent is highly desirable. ASQ (CQE, CRE, CQA) Certifications a plus.

EXPERIENCE

• 2-3 years of experience as a Data Analyst, Quality/Reliability Engineer, Design Engineer working within the framework of a Quality System.

• Experience with medical device manufacturing with electronic and/or electromechanical products preferred.

• Excellent written and verbal communication skills with demonstrated ability to work cross-functionally across different functional groups and demonstrated ability to prioritize and manage multiple tasks and projects effectively and efficiently.

• Experience with design review processes, and capable to perform risk analysis in accordance with EN ISO 14971:2012 and develop and document risk mitigation plans desired. Previous experience with SAP MRP or QM module and TW desired

• Working knowledge of EU MDR requirements, particularly Annex I, the General Safety and Performance Requirements, (GSPR).

You will be a part of:

You are empowered to use your voice and expertise to have a positive impact on your team, the business, and health technologies that will improve the health, well-being and care for people around world.  You will be part of the Hospital Respiratory Care Quality team. 

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.