Siemens Healthineers · 2 months ago
Quality Engineer – Supplier & Product
Hoffman Estates, IL
Full-time
Onsite
Senior Level
$82K/yr - $112K/yr
5+ years expSiemens Healthineers is a leader in medical technology, seeking a Quality Engineer focused on Suppliers and Products. The role involves ensuring product quality meets customer requirements and regulatory standards while collaborating with various teams to establish qualification criteria and manage supplier quality plans.
Health CareHealth DiagnosticsMedicalMedical Device
Responsibilities
Working closely with Engineering, Purchasing, and suppliers to establish new product qualification criteria and defining, supporting, and implementing supplier quality plans and first article inspections (FAI)
Collaborating with Engineering and reviewing requirements with suppliers to ensure technical requirements are clearly understood
Validating that all engineering deviations and substitutions are properly approved and documented
Approving, developing, and managing all direct and indirect quality-relevant material suppliers and ensuring received materials conform to specifications
Reviewing design specifications and developing material inspection plans within SAP ERP for use by incoming inspection personnel to assess material conformance, while providing guidance and assistance as needed
Conducting audits at supplier sites to qualify management systems and manufacturing capabilities and providing risk analyses and mitigation plans to address gaps
Developing and maintaining supplier performance KPIs and utilizing them to assess quality trends, set performance targets, and verify the effectiveness of corrective actions
Analyzing complex non-conforming material situations to determine root causes and defining effective corrective action plans, while evaluating supplier responses to SCARs for completeness and effectiveness
Utilizing basic statistical analysis methods to evaluate processes and corrective actions to determine control status and overall effectiveness
Conducting on-site supplier QMS or process audits and driving corrective and preventive action (CAPA) plans
Accompanying and supporting customers during external reference site visits to ensure confidence in supplier and product quality
Participating in knowledge exchange with R&D teams to continuously improve and further develop products and software solutions
Qualification
Required
BS degree in Electrical & Electronics / Mechanical Engineering
5+ years of progressively responsible experience in a quality discipline or related field, and successful demonstration of key responsibilities and job knowledge
Preferred
Demonstrating experience in conducting both quality system and product audits at supplier or subcontractor facilities, domestically and internationally
Completing formal audit training from an accredited organization (ASQ or ANSI-RAB NAP) and holding an ASQ-CQA or RAB certification
Achieving and maintaining ASQ-CQE certification
Possessing in-depth knowledge and training in ISO 13485 and ISO 9001 standards
Applying quality assurance methodologies such as Six Sigma, Statistical Process Control (SPC), Gage R&R, FMEA, and Poka-Yoke to analyze and control key process parameters
Showing proficiency in Microsoft Office, with strong emphasis on Excel; experience with Minitab is a plus
Benefits
Medical insurance
Dental insurance
Vision insurance
401(k) retirement plan
Life insurance
Long-term and short-term disability insurance
Paid parking/public transportation
Paid time off
Paid sick and safe time
Company
Siemens Healthineers
Siemens Healthineers is a healthcare technology company that provides diagnostic and therapeutic products and services. It is a sub-organization of Siemens.
10001+ employees
H1B Sponsorship
Siemens Healthineers has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (104)
2024 (70)
2023 (64)
2022 (89)
2021 (50)
2020 (86)
Funding
Current Stage
Public CompanyTotal Funding
$2.76BKey Investors
Ontario Together Fund
2021-05-25Grant· $2.5M
2021-03-25Post Ipo Equity· $2.76B
2018-03-16IPO
Leadership Team
Enno Nehrbass
SVP / Head of Strategy & Collaboration Mgmt Diagnostic Imaging
Anton Ebert
Technology Focus Topic Lead - Digital Twinning
Recent News
2026-02-03
Medical Device Network
2026-02-02
Company data provided by crunchbase