Product Quality Specialist
We are seeking a Product Quality Specialist to bridge Quality and R&D, ensuring hardware and software designs meet the highest standards of quality, reliability, and compliance from concept to production.
* Collaborate with R&D to assess and influence product designs for quality, reliability, and regulatory compliance.
* Evaluate schematics, PCB layouts, and hardware specifications to identify design-related quality risks.
* Lead risk assessments (e.g., DFMEA) and drive root cause analysis for design-related issues.
* Support validation and verification activities within the NPI process.
* Work closely with Purchasing and R&D on new vendor and component approvals to ensure supplier quality standards are maintained.
* Perform statistical analysis and reporting of product test data.
* Provide quality oversight and support for software and hardware testing.
* Partner with Production, Test Engineering, and Process Quality teams to resolve product and process issues.
* Maintain design traceability and compliance with internal and external standards.
* Represent Quality in design reviews and product development meetings.
* Support audits and regulatory inspections related to design controls.
* Drive continuous improvement in design and quality processes.
The ideal candidate will have:
* A Bachelor's degree in Electronic, Electrical, Software, or related Engineering discipline.
* 5+ years' experience in a Quality or R&D role within a regulated or high-reliability industry (e.g., life safety, medical devices, aerospace, or automotive).
* Strong understanding of product development lifecycle and design control processes.
* Experience with hardware/software integration and testing.
* Familiarity with ISO 9001 or similar quality standards.