In this role, you have the opportunity to
guide and support Business Groups, Markets and enabling functions to always do the right thing. This involves being a confident advisor on approval, regulatory compliance and quality management related topics, in order to achieve timely releases of innovative products that deliver high quality and outstanding reliability to the lives they will improve.
You are responsible for
developing and implementing systems to ensure products or services are designed and produced to meet or exceed customer requirements and expectations. Participates in the change management process to assure the products or services continue to meet customer requirements. Participate with cross-functional team with other business and engineering disciplines. Establish the principles of product and service quality evaluation and control for the system. Provide independent oversight and review of the project deliverables throughout the product lifecycle. Provides leadership and is responsible and accountable to the organization for own decisions and actions, while also holding others accountable for the same. Working in the medical industry brings much fulfillment, as well as unique challenges. As part of our HealthTech – focused company, you will be responsible to drive product quality improvement activities, using statistics and data analysis techniques to improve processes.
Key areas of responsibilities for this role include:
Is a member of R&D teams (e.g. the development team in a product development project) and ensures that software designs meet quality and compliance standards for every milestone and reviews project and product documentation
Defines and executes a fast quality feedback plan that supports risk management activities and design quality related activities during all stages of the product/system lifecycle (as independent role in Q&R whilst closely working together with R&D teams)
Validates key design inputs like: Usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability and costs
Performs independent technical assessments on product quality performance and leads quality related problem solving and root cause analysis during design and manufacturing
Performs independent assessments (internal audits) of the way-of-working or product quality
You are a part of
As a result of Philips renewed commitment to Quality, it has recently restructured its organization to ensure you and your department have clear interfaces with Philips Business Group and Market leadership, and can harness the expertise of five Centers of Excellence (COEs). These 5 COEs specialize in the following capabilities: Regulatory & Clinical Affairs, Supplier Quality, Quality Management System, Quality Assurance & Engineering, and Compliance & Audit. As part of this new structure, you are empowered to use your voice and expertise to have a positive impact on your team, our business, and health technologies that will improve the health, well-being and care for people around world.
To succeed in this role, you should have the following skills and experience
We are looking for a perfectionist- a fixer who continuously strives for excellence as a way of life; not just as a job. We’re looking for someone who can inspire others to adopt this mentality of prioritizing quality above all else in a relentless pursuit to improve the quality of life billions for the billions of people Philips brand touches each year.
Specific skill requirements for this role include:
Bachelor’s degree in software engineering or equivalent demonstrated strong technical competence
Minimum of 3+ years of experience in a medical device (preference), aerospace, automotive or other regulated industry
Software design experience (product quality, reliability engineering)
Required competencies: Basic understanding of global medical device regulations, requirements, and standards, such as 21 CFR Parts 803, 806, and 820, ISO13485, ISO9001, and ISO 14971
Required knowledge of Statistical sampling / Design of experiments (DOE) / Statistical process control (SPC) / Risk Management (DFMEA, PFMEA) / Reliability Testing (e.g. MTBF, HALT, HASS) / APQP / Design Transfer / Design for Manufacturing (DfM) / Lean Methodologies / PDCA – 8D, 5-Why, DMAIC / Tolerance trains
Have an understanding of the audit process including types of audits, planning, preparation, execution, reporting results, and follow-up. Experience as auditor/facilitator is an advantage