Siemens HealthineersRemote
Quality Engineer – Electrical & Mechanical Components
United States of America
Full Time
4 hours ago
$89,000 - $123,000 USD
H1B Sponsor Likely
Key skills
Quality EngineeringSupplier Quality EngineeringManufacturing QualityRoot Cause AnalysisCorrective ActionEngineering DrawingsGD&TManufacturing ProcessesFirst Article Inspection (FAI)Supplier AuditsSupplier Performance ManagementNon-Conformance ManagementSupplier Corrective Action Requests (SCAR)Deviation ManagementISO 13485ISO 9001IATF 16949Six SigmaStatistical Process Control (SPC)Failure Mode and Effects Analysis (FMEA)Gage R&RPoka-YokeASQ CQE CertificationASQ CQA CertificationMicrosoft ExcelSAP ERPMinitabRStatistical AnalysisERPSAPCommunicationCollaboration
About this role
Siemens Healthineers is a leader in medical technology, and they are seeking a Quality Engineer – Electrical & Mechanical Components. This role involves ensuring supplier, manufacturing, and product quality throughout the product lifecycle by collaborating with various teams and driving continuous improvement initiatives.
Responsibilities:
- Partnering with Engineering, Purchasing, Manufacturing, and suppliers to establish qualification criteria for new products and components, including First Article Inspections (FAIs)
- Collaborating with suppliers to ensure engineering drawings, specifications, and technical requirements are fully understood
- Developing and maintaining supplier performance scorecards while identifying trends, driving continuous improvement, and partnering with suppliers to improve quality performance
- Investigating non-conforming materials by performing root cause analysis and partnering with Engineering, Manufacturing, and suppliers to determine appropriate disposition and corrective actions
- Leading Supplier Corrective Action Requests (SCARs) and verifying the effectiveness of corrective and preventive actions
- Monitoring supplier performance metrics and quality trends while identifying opportunities to improve supplier performance and reduce quality risks
- Developing supplier quality plans and inspection strategies for incoming materials
- Reviewing engineering deviations and substitutions to ensure proper approval and documentation
- Conducting supplier quality system and process audits while assessing manufacturing capability and identifying areas for improvement
- Performing supplier risk assessments and supporting supplier development initiatives
- Utilizing statistical analysis tools to evaluate process capability and verify corrective action effectiveness
- Supporting manufacturing teams by troubleshooting supplier-related quality issues and driving timely resolution
- Participating in cross-functional continuous improvement initiatives across Engineering, Manufacturing, Purchasing, and Quality
Requirements:
- Bachelor's degree in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, Manufacturing Engineering, Industrial Engineering, or a related engineering discipline
- 3+ years of experience in Quality Engineering, Supplier Quality, Manufacturing Quality, or a related engineering role
- Experience working with suppliers, manufacturing processes, and engineering teams to resolve quality issues
- Experience conducting root cause investigations and driving corrective actions
- Strong understanding of engineering drawings, specifications, GD&T, and manufacturing processes
- Excellent communication and cross-functional collaboration skills
- Supplier Quality Engineering
- Supplier Audits
- Supplier Performance Management
- Non-Conformance Management
- Supplier Corrective Action Requests (SCAR)
- Root Cause Analysis
- First Article Inspection (FAI)
- Deviation Management
- ISO 13485, ISO 9001, AS9100, IATF 16949, or similar quality management systems
- Six Sigma, SPC, FMEA, Gage R&R, Poka-Yoke
- ASQ CQE, CQA, or equivalent certifications
- Microsoft Office (Excel) and SAP ERP; Minitab experience is a plus