Process Quality Engineer 2

　　The Process Quality Engineer 2 will work primarily with manufacturing processes and engineering counterparts in Advanced Engineering or Design Assurance 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 as well as the introduction of new manufacturing line processes, or transfer of existing processes from other facilities into Costa Rica.

　　Lead a group of direct report (Quality Inspectors, Technicians or Engineers) as required.

　　Responsibilities

　　Ensures that appropriate quality plans are made and a suitable quality system is in place, for both NPI’s as well as for ongoing manufacturing that include all stages of the manufacture of the product/system and supports Quality System design.

　　Validate risk analyses and risk mitigation plans and activities, control plans, and Quality Systems Oversee processes: trend analysis, assess impact and follow-up (e.g., in QS updates, control plans, competency upgrades, etc.).

　　Review calibration plans and records, environmental controls, and training plans and records. Organize IQA audits, and execute internal audits for regulated products to assess the effectiveness of the QMS linked to production controls.

　　Approve which processes need validation/re-validation after changes, and verify processes and plans/records.

　　Requirements

　　Bachelor’s degree in engineering disciplines or related field or a combination of equivalent job experience in related field.

　　Requires 5+ years' experience in Quality Engineering related activities.

　　Intermediate/Advanced English skills

　　Desirable ability to interpret technical drawings that may include mechanical dimensioning and Geometric Dimensioning and Tolerance (GD&T).

　　Strong knowledge of Measurement and Test tools e.g. calipers, micrometers and methodologies for inspection (i.e. appropriately apply destructive and non-destructive testing) is preferred.

　　Strong and proven knowledge of statistical methods and the use of standard quality tools (e.g. flowcharts, Pareto charts, cause and effect diagrams, control charts, regression analysis, etc).

　　Proven knowledge and application of applicable regulations for Medical Device manufacturing.

　　Proven ability to understand and interpret established quality system requirements and provide advice to project teams and the organization in general on how to remain compliant to requirements during execution.

　　Onsite

　　Shift B.

　　Monday thru Friday From3:36 p.m. to 10:00 p.m.Saturday From 7:00 a.m. to3:00 p.m.

　　About Philips

　　We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.

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　　Discover our rich and exciting history.

　　Learn more about our purpose.

　　If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.

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