Quality Engineer - Products and Systems
Job Description
Job Title
Quality Engineer - Products and Systems
Job Description
In addition to the below responsibilities, this role also need skill set on X-ray radiation to perform Radiation Officer within the Design Quality function. The Quality Engineer is accountable for oversight of system and hardware quality and risk management throughout the product life cycle.
The Quality Engineer provides independent oversight of the design input process, design V&V activities, design transfer and product realization, and performance in the field to ensure that all design requirements are effectively met.
The Quality Engineer also provides analytics to the Business on the efficacy and efficiency of the design and product realization processes
You are responsible for:
- To drive compliance of Design control requirements and ensure product design quality met in new product development as well released product.
- To ensure radiation safety regulations and requirements as per IEC standard / FDA guidelines are met in the product design
- Challenge the status quo on EMI/EMC impacts during product design change
- Collaborate with R&D Compliance team for CDR development in NPI
- Monitor design control requirements are adhered in the NPI project as part of project core team
- Provide appropriate decision on project readiness to next phase / milestone considering quality aspects
- Provide necessary process guidance and compliant solution to project team
- Challenge the status quo of Reliability targets in NPI project
- Deriving business solution by collaborating with cross functional team members
- Provide support on E2E process guidance for issues reported on released product
- Establish and support best practices for problem solving, root cause analysis, and solution selection tools
- Provide subject matter expertise during internal and external quality system audits
To succeed in this role, you should have the following skills and experience:
- Engineering degree in Mechanical or Electronics/Bio medical /Life sciences
- Minimum 15 years hands on experience in X-ray machines, Radiation devices (Subchapter J), IEC 60601 standards, along-with knowledge on Risk management and Medical device quality system for product development
- Profound knowledge on IEC 60601 compliance standards, Radiation safety requirements e.g. 2-54, Subchapter J Radiological Health and Product quality aspects
- Sound knowledge of implementing and sustaining Quality Management system compliance as per ISO Regulations (ISO13485/ USFDA QSR)
- Demonstrated external audit management capabilities like handling Notified body audits/FDA audits/ Internal audits with stake holder management &Follow up for E2E corrective actions completion
- Superior knowledge/application of all Quality System elements within Medical device Industry
- Demonstrated record of successful project management, process development, and process improvement in QMS implementations and trainings
- Superior communication and mentoring skills, ability to build consensus at all levels including global interactions
- Demonstrated quality training delivery experience
About Philips
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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 .
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