Philips Quality Specialist in Blumenau, Brazil

Your challenge

As the incumbent of this Quality & Regulatory (Q&R) role within Philips, your challenge will be to guide and support TASY/EMR Business 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 & services that deliver high quality and outstanding reliability to the lives they will improve.

Your responsibilities

•Support site Q&R lead to implement the Business’ long-range quality, regulatory and compliance policy

•Create Q&R awareness level as determined within the organization.

•Enforces (a simplified) quality systems and harmonizes them across the Business

•Introduce and implement the quality processes and tools required to ensure product quality and customer satisfaction.

•Manage compliance to FDA regulations and other Regulatory Agencies as required, guidelines and policies to all products and operations are consistent with those regulations.

•Manages the review and approval of finished products developed for and by the company in accordance with their approved specifications.

•Ensures training- & competence management in line with PQMS requirements.

•Manage and monitor CAPA process

Your team

Philips Healthcare Solutions & Services (HISS)/EMR belongs to the most innovative Business in Royal Philips.

Associated locations and team members you will closely work with are located in USA, Germany, India and Netherlands. It is an additional challenge to work in such diverse cultural environment – but very exiting at the same time.

We are looking for

•A seasoned, experienced professional with a full understanding of area of QMS; able to resolve a wide range of issues in creative ways.

•Somebody able to lead a cooperative effort among members of a project team

•Able to work 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.

•Acting as advisor to subordinate(s) to meet schedules and/or resolve problems.

Education

Bachelor degree

or adequate professional experience in Quality environment

Experience

Quality Engineering

Project Management

CAPA execution

Location: Blumenau, Brazil

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