
Posted 4 days ago
Supplier Quality Engineer
Siemens HealthineersSupplier Quality Engineer
Perks & benefits
Health InsuranceMedical InsurancePaid Leave
Requirements
BS Electrical or Mechanical Engineering, 5+ years quality discipline experience, ISO 13485 and ISO 9001 knowledge, Audit training (ASQ or ANSI-RAB NAP), Statistical analysis proficiency
Skills
ISO 13485Six SigmaSAP
About the role
Responsibilities
- Establish new product qualification criteria and implement supplier quality plans and first article inspections (FAI)
- Collaborate with Engineering to ensure technical requirements are clearly understood by suppliers
- Approve, develop, and manage direct and indirect quality-relevant material suppliers
- Conduct on-site supplier QMS or process audits to qualify management systems and manufacturing capabilities
- Develop and maintain supplier performance KPIs to assess quality trends and verify corrective actions
- Analyze complex non-conforming material situations to determine root causes and define corrective action plans
- Utilize statistical analysis methods to evaluate processes and determine control status
- Drive corrective and preventive action (CAPA) plans following audits
Requirements
- BS degree in Electrical & Electronics or Mechanical Engineering
- 5+ years of progressively responsible experience in a quality discipline or related field
Preferred Qualifications
- Experience conducting quality system and product audits at supplier facilities, domestically and internationally
- Formal audit training from an accredited organization (ASQ or ANSI-RAB NAP)
- ASQ-CQA, RAB, or ASQ-CQE certifications
- In-depth knowledge of ISO 13485 and ISO 9001 standards
- Proficiency in quality assurance methodologies such as Six Sigma, SPC, Gage R&R, FMEA, and Poka-Yoke
- Proficiency in Microsoft Office (strong Excel skills) and experience with Minitab
Benefits
- Medical, dental, and vision insurance
- 401(k) retirement plan
- Life, long-term, and short-term disability insurance
- Paid time off, paid sick, and safe time
- Paid parking or public transportation assistance
About the Company
Siemens Healthineers is a global medical technology leader with more than 72,000 dedicated professionals in over 70 countries. We strive to pioneer breakthroughs in healthcare to improve patient outcomes and experiences worldwide.
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Siemens Healthineers · Hoffman Estates
