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Philips Quality Manufacturing Engineer Costa Rica 503555385
26.07.2024
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Quality Manufacturing Engineer
Job Description
Job Description
528451 Quality Manufacturing Engineer 2
Oversees the Quality Assurance in the processes related to the product transfers, NPI and Design Changes to ensure manufacturing of materials, components, sub-assemblies, and completed products and their supply chain, are in compliance to regulatory requirements and/or procedures for regulated products/businesses. The processes include the introduction/validation of new/changed manufacturing processes and their associated Quality systems, the trend analysis and monitoring of manufacturing processes and their environment, the remediation to non-conformances, and the development and improvement of Quality systems.
Responsibilities
• Ensures that appropriate quality plans are made and a suitable quality system is in place, for Product Transfers, NPI’s, Design Changes 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.
•Approve which processes need validation/re-validation after changes, and verify processes and plans/records.
•Manage and improve compliance to FDA regulations and other Regulatory Agencies as required.
•Business process expert for processes in scope, acting in support of the local business QMS lead and QMS element owners across the business to deploy harmonized and standardized Philips processes.
•Support external and internal audit readiness and provide support during external and internal audits.
•Actively participate in Quality & Regulatory initiatives as a cross functional contributor.
•Drive local QMS transformation towards harmonized and standardized Philips QMS.
•Demonstrate operational excellence and ensure quality in all deliverables.
•Establish and ensure adherence to schedules, work plans.
•Establishes local operational objectives and work plans."
Requirements
- Bachelor’s degree in engineering disciplines or related field or a combination of equivalent job experience in related field.
- 2+ years’ work experience in Quality or Manufacturing or other related fields.
- Intermediate/advanced English skills
- Knowledge in Minitab intermediate, SAP basic
- 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).
- Basic understanding of global medical device regulations, requirements, and standards, such as:21 CFR Part 820, ISO13485
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