Quality Assurance Specialist
2 weeks ago
Job Summary
We are seeking a highly skilled Quality Assurance Specialist to join our team at Philips. As a Quality Assurance Specialist, you will be responsible for ensuring the quality and safety of our medical devices.
Key Responsibilities
- Drive compliance of Design control requirements and ensure product design quality meets in new product development as well as released product.
- 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.
Requirements
- 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 stakeholder 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.
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