Sr. Design Quality Engineer
Sr. Design Quality Engineer (Randstad Contingent Worker)
This position is fully remote if home-based in the United States.
In this role, you will have the opportunity to:
- Perform a wide variety of activities to be compliant with applicable regulatory requirements, quality management system (QMS) maintenance, improvement of product quality, quality control and assurance.
You will be responsible for:
- Participate in leading Quality, Reliability and Safety of Medical and Non-Medical Devices. Champion design and product quality with cross-functional project teams Lead Design Quality processes and projects aspect. Improve Product Quality and quality processes. Contribute to achieve quality objectives as they relate to Patient safety Product QualityÂ Customer experience (voice of the customer) Complaint Rate (Cost of Non-Quality, Recalls, Complaints, DEFOA) First Pass Yield (avoid scrap, rework). Work from within an independent Q&R organization with key stakeholders of the Business during the various stages of the design, development, and maintenance of the product. Experience with Product Quality triggers, what in a process might trigger a product quality issue. Risk based approach analytical skills. SME (Subject Matter Expert) in all design control, Patient safety and product quality aspects.
To succeed in this role, you should have the following skills and experience:
- Experience: Minimum 20 years professional experience in the applicable role.
- Education: Bachelor's /Master's degree in Engineering. Significant leadership experience in role.
- Quality Engineering position that covers a broad range of R&D activities crossing things such as Sample Size Statistics, confidence and Tolerance Intervals, Risk Assessment, Chain of Custody, Supplier Qualifications, IQ/OQ/PQ, tooling, CpK, test methods, and a long list of interests in SOPs, Work Instructions, Checklists and more. Actively participate and drive improvement activities as required. Assure deployment of appropriate validation planning and robust design transfer, Apply subject matter expertise in Process Excellence, 6 Sigma, and CQE tools where appropriate, Review, evaluate and endorse investigation documentation for incidents and deviations, Provide QA support to manufacturing departments, Evaluate and update existing SOP’s for cGMP compliance, Facilitate, coordinate and champion investigations, Perform and participate in investigations, Participate in and perform internal audits, Communicate and determine disposition for quality issues within the facility. Participate in the Annual Product Review report process, Develop and maintain metrics / trending for incidents, deviations and CAPA items, assist in the application of appropriate quality technology tools to establish and maintain process capability and to resolve deviations and non-conformances, experience may include Quality and Regulatory aspect of manufacturing, Validation and Design Control, Metrics, Data Analysis and Statistical Techniques, Investigations and Root Cause Analysis, CAPA and NC and Lean Six Sigma tools.
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.