Design Quality Assurance Specialist
1 week geleden
We are seeking a highly skilled Design Quality Engineer to join our Patient Safety and Quality organization. As a key member of our team, you will play a critical role in ensuring the quality and reliability of our medical devices.
Key Responsibilities:- Provide independent oversight of the design input process, design verification and validation activities, design transfer, and product realization to ensure that all design requirements are effectively met.
- Develop and implement quality plans that include all stages of the product's lifecycle and support quality plan design.
- Validate key design inputs such as usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability, and costs.
- Lead quality problem-solving and drive design for reliability and design for six sigma initiatives.
- Act as a single point of contact in project teams for end-to-end design quality.
- Ensure the voice of the customer is represented in project teams.
- Use post-market data for analytics and statistics to report on the product's performance in the market and initiate field actions when required.
- Ensure the product's design quality-related requirements/criteria are complete and meet the quality standards for every project milestone.
- Engineering degree.
- Experience in quality- or reliability engineering in the medical or aerospace industry.
- Ability to define detailed quality and reliability plans for new medical product developments to ensure they are safe, effective, and reliable.
- Ability to contribute to risk management and lead FMEA activities for new products and ensure that control measures are translated into appropriate (critical) requirements.
- Strong exposure to the application of design controls and ability to conduct thorough design reviews during new product development to ensure robust designs that further improve patient safety and product quality.
- Ability to partner with V&V teams to assure thorough verification, validation, and usability testing.
- Ability to analyze development and field data for trends of product safety, quality, and reliability performances and areas for further improvements of product design and related development processes.
- Ability to conduct reliability analysis to assess the risks associated with design concepts.
- Experience with adequate and accurate review of DHF and DMR documents.
- Understanding of global medical device regulations, requirements, and standards, such as 21CFR820, ISO13485, EU MDR, IEC 62366, IEC 62304, and ISO 14971.
- Experience with working in multidisciplinary teams in a high-tech R&D environment.
- You continuously strive for excellence as a way of life and can inspire others to adopt this mentality of prioritizing quality above all else.
- You are a self-starter who embraces change.
The opportunity to play a key role in our Patient Safety and Quality transformation journey.
The chance to make an impact in supporting the strategic imperative to raise the bar on quality and bring our innovations faster to the customers.
Working at Philips is more than a job. It's a calling to create a healthier society through meaningful work, focused on innovative, customer-first health technology solutions. Help us improve the health and well-being of billions of people, every year. Ultimately creating a career that no one could have planned for. Even you.
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Design Quality Assurance Engineer
2 weken geleden
Best, Noord-Brabant, Nederland Philips VoltijdAbout the Role:We are seeking a highly skilled Design Quality Assurance Engineer to join our team at Philips. As a key member of our global Patient Safety and Quality organization, you will play a critical role in ensuring the quality and reliability of our medical devices.Key Responsibilities:Provide independent oversight of the design input process, design...
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Design Quality Assurance Specialist
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Best, Noord-Brabant, Nederland Philips VoltijdJob Title: Design Quality EngineerAs a Design Quality Engineer at Philips, you will play a critical role in ensuring the quality and reliability of our medical devices. Your primary responsibility will be to provide independent oversight of the design input process, design verification and validation activities, design transfer, product realization, and...
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Best, Noord-Brabant, Nederland Philips VoltijdJob Title: Design Quality EngineerAs a Design Quality Engineer at Philips, you will play a critical role in ensuring the quality and reliability of our medical devices. Your primary responsibility will be to provide independent oversight of the design input process, design verification and validation activities, design transfer, product realization, and...
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Best, Noord-Brabant, Nederland Philips VoltijdDesign Quality Engineer RoleWe are seeking a highly skilled Design Quality Engineer to join our Patient Safety and Quality organization. As a key member of our team, you will play a critical role in ensuring the quality and reliability of our medical devices.Key Responsibilities:Provide independent oversight of the design input process, design verification...
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