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Philips Manufacturing Quality Engineer United States, Pennsylvania 588167739
Manufacturing Quality Engineer will oversee the Quality Assurance in the processes related to the manufacturing of materials, components, sub-assemblies, and completed products and their supply chain, including compliance to regulatory requirements and/or procedures for regulated products/businesses. The processes include theof 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.
In this role, you are responsible for:
- Ensuring 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
- Validating risk analyses and risk mitigation plans and activities, control plans, and Quality Systems.
- Reviewing calibration plans and records, environmental controls, and training plans and records
- Organizing IQA audits, and execute internal audits for regulated products to assess the effectiveness of the QMS linked to production controls
- Approving which processes need validation/re-validation
- BS in Mechanical Engineering, Biomedical Engineering, Process Engineering or related technical discipline, preferred.
- 5+ years of engineering experience in the related field or a combination of equivalent education and relevant experience.
- Solid experience in Risk Management for medical devices ISO 14971 is desired
- Regulated industry experience is preferred
- Knowledge of statistical analysis (Minitab)
- Proficiency in the use of various measuring tools and troubleshooting equipment
You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this
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 improve the lives of others.
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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 .
For this position, you must reside inwithin commuting distance to
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