Philips Quality & Regulatory Manager in Blumenau, Brazil
Cardiology is one of the four growth pillars of Philips. To accelerate our growth ambition of doubling our business by 2020, we are currently looking for a Quality Engineer for our Cardiology Informatics (CI) business. You will be working in a cross-functional international team which develops cardiology informatics products. You will perform activities to ensure compliance to regulatory requirements and procedures as documented in the Quality Management System of CI and as required by for medical devices which are sold worldwide.
Verification of execution of processes and their deliverables in product creation and subcontracting projects and report the findings to upper management.
Review and Approval of designated project documentation in product creation projects.
Advise to product creation projects concerning the definition and implementation of quality assurance activities
Advise upper management with respect to release for delivery of products
Support and represent Q&R discipline in Design Reviews, Hazard Analysis brainstorms, Health Risk Assessments
Represent the approbation officer in projects and support in the activities to acquire product licenses and approvals
Participation in and verification off changes to DMR and release orders where Q&R involvement is needed.
Participates in the maintenance and improvement of the Quality Management System
Drive the execution of and/or support and advice the organization in corrective and preventive actions
Initiate, stimulate, support the implementation of process improvements
The Quality Assurance (QA) and Quality Engineering (QE) team of CI is located in the Netherlands and being built in Blumenau Brazil. It is part of the Business Group (BG) Healthcare Informatics Solution Services (HISS) international QA/QE team of about 20 people. In this role, your manager is the Head of QA/QE of the BG HISS. For your daily activities you will report to the Q&R lead of CI and to the project managers of the innovation projects to which you are assigned.
We welcome you to a challenging, innovative international environment with great opportunities for you to explore.
You will be working at the heart of one of the growth areas within Philips.
Many opportunities to learn and grow, using an extensive set of tools and support from our business.
A workplace geared to support new development methods.
An enthusiastic and fast growing team that works closely together and collaborates globally.
We are looking for
Bachelor/Master Degree in Informatics or other relevant science
3-5 years of total industry experience with at least 2 years of related experience in a medical device or other regulated industry is required
Working knowledge of appropriate global medical device regulations or other regulated industry, requirements and standards is required
Expertise/experience in root cause analysis, corrective/preventive action methods and problem solving with quality tools such as: 6-sigma / 8-D / CAPA / FMEA/ 5WHY etc.
Good knowledge of Software/quality development and control methods;
Very good communication and documentation skills
Fluent in English; speaking, reading and writing.
Proactive, independent, target oriented and self-motivated