In this role, you have the opportunity to
The Process Quality Engineer 2 will work primarily with Philips-Volcano manufacturing processes in support of product inspections, and product and process compliance to established procedures and will take corrective and preventive action as required by procedures to support the continued operation of the Costa Rica site manufacturing lines. The Quality Engineer 2 will also be assigned improvement or remediation project activities in support of the organization’s needs for continuous improvement or maintenance of regulatory compliance.
You are responsible for
Review reported manufacturing process problems and determine the best course of action within Volcano’s quality system to address the product or process problem. Execute the necessary actions to bring products and processes back to conformance within the quality system requirements.
Generate, review and approve as applicable manufacturing process changes deliverables for adequate impact assessment and compliance to applicable production process controls.
Generate, review and approve as applicable quality system documents needed for production operations (Calibrations, Maintenance, etc).
Support assigned areas improvement projects (Lean, Yield improvements, Complaint reduction initiatives)
As necessary, performs other duties as required.
You are a part of
A leading health technology company with a multinational workforce of approximately 77,000 employees and globally present with sales and services in more than 100 countries worldwide.
To succeed in this role, you should have the following skills and experience
KNOWLEDGE AND EXPERIENCE DESIRABLE:
Requires 2+ years’ experience in the medical device industry or regulated industry
Ability to interpret technical drawings that may include mechanical dimensioning and Geometric Dimensioning and Tolerance (GD&T).
Knowledge of Measurement and Test tools (e.g. calipers, micrometers, Coordinate Measuring Machines (CMM), etc) and methodologies for inspection (i.e. appropriately apply destructive and non-destructive testing) is preferred.
Solid knowledge of statistical methods and the use of standard quality tools (e.g. flowcharts, Pareto charts, cause and effect diagrams, control charts, scatter diagrams, regression analysis, affinity diagrams, etc).
Understanding and training in applicable regulations for Medical Device manufacturing.
In return, we offer you
In order to develop your full potential, we will offer you the flexibility, encouragement and opportunities to keep you inspired and engaged. After all, working at Philips is more than a job. It is an experience full of amazing moments that will transform you in a lasting and positive way, since together we can improve the world.
Philips is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex (including pregnancy), sexual orientation, gender identity, national origin, genetic information, creed, citizenship, disability, protected veteran or marital status.