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Supplier Quality Engineer

Siemens Healthineers

Any City, USOnsitePosted 15 days ago$84,200 - $115,775
Full TimeSenior LevelQuality (QA / QC)Medical Device
Original posting ↗

Summary

The position includes conducting supplier-site audits to evaluate management systems and manufacturing capabilities, identifying gaps, and creating risk-analysis and mitigation plans. The Quality Engineer also develops and maintains supplier performance key performance indicators, uses them to assess quality trends and establish performance targets, and verifies whether corrective-action plans are effective. The role further includes conducting supplier quality management system and process audits at domestic or international sites and driving resulting corrective-action plans.

Job description

Core Responsibilities

Supplier Qualification and Quality Planning

  • Work with Engineering, Purchasing, and suppliers to establish new-product qualification criteria and create, support, and implement supplier quality plans and first article inspections.
  • Collaborate with Engineering and suppliers to ensure that technical requirements are clearly understood.
  • Verify that engineering deviations and substitutions receive appropriate approval and documentation.
  • Approve, develop, and manage direct and indirect quality-relevant material suppliers while ensuring that received materials conform to requirements.
  • Review design specifications and develop material inspection plans in the SAP enterprise resource planning system for incoming inspection personnel, while providing guidance to inspection staff when needed.

Audits, Risk Management, and Supplier Performance

The position includes conducting supplier-site audits to evaluate management systems and manufacturing capabilities, identifying gaps, and creating risk-analysis and mitigation plans. The Quality Engineer also develops and maintains supplier performance key performance indicators, uses them to assess quality trends and establish performance targets, and verifies whether corrective-action plans are effective. The role further includes conducting supplier quality management system and process audits at domestic or international sites and driving resulting corrective-action plans.

Nonconformance and Corrective Action

The successful candidate analyzes complex nonconforming-material situations and their interrelationships, determines root causes, and establishes appropriate corrective-action plans. The role also involves evaluating supplier responses to formal supplier corrective action requests for thoroughness and effectiveness. Basic statistical analysis methods are used to assess processes and corrective-action plans, determine the state of process control, and evaluate the effectiveness of implemented actions.

Collaboration and Product Development

Additional responsibilities include accompanying and supporting customers during external reference-site visits and exchanging knowledge with the research and development team to improve and further develop products and software solutions.

Required Qualifications

  • A Bachelor of Science degree in Electrical, Electronics, or Mechanical Engineering.
  • 5 years of progressively responsible experience in a quality discipline or related field, together with demonstrated knowledge of the role’s key responsibilities.

Preferred Experience and Skills

  • Experience conducting quality-system and product audits at supplier or subcontractor facilities, both domestically and internationally.
  • Audit training from an accredited source, such as ASQ or ANSI-RAB NAP, leading to ASQ-CQA or RAB certification.
  • An earned and maintained ASQ-CQE certification.
  • Knowledge of or training in ISO 13485 and ISO 9000.
  • Training and implementation experience in quality-assurance methods for analyzing and controlling key process parameters, including Six Sigma, statistical process control, gage repeatability and reproducibility, failure mode and effect analysis, and Poka-Yoke.
  • Proficiency with Microsoft Office, particularly Excel; Minitab experience is an advantage.

Requirements

  • Bachelor of Science degree in Electrical, Electronics, or Mechanical Engineering
  • 5 years of progressively responsible experience in a quality discipline or related field
  • Demonstrated knowledge of supplier quality responsibilities
  • Experience conducting quality-system and product audits at supplier or subcontractor facilities, domestically and internationally
  • Audit training from an accredited source (e.g., ASQ or ANSI-RAB NAP) leading to ASQ-CQA or RAB certification
  • Earned and maintained ASQ-CQE certification
  • Knowledge of or training in ISO 13485 and ISO 9000
  • Training and implementation experience in quality-assurance methods: Six Sigma, statistical process control, gage R&R, FMEA, Poka-Yoke
  • Proficiency with Microsoft Office, particularly Excel
  • Minitab experience

Benefits

  • Medical Insurance
  • Dental Insurance
  • Vision Insurance
  • 401(k) Retirement Plan
  • Life Insurance
  • Long-Term Disability Insurance
  • Short-Term Disability Insurance
  • Paid Parking or Public Transportation
  • Paid Time Off
  • Paid Sick and Safe Time

Company overview

Siemens Healthineers is a German multinational medical technology company specializing in diagnostic and therapeutic imaging, laboratory diagnostics, and molecular medicine. Founded in 2017 as a spin-off from Siemens AG, the company has established itself as a global leader in healthcare technology with a comprehensive portfolio that addresses the complete care continuum for many of the world's most threatening diseases. With approximately 69,500 employees worldwide and operations in over 70 countries, Siemens Healthineers generates annual revenues exceeding €21 billion. The company's product offerings span across four main business segments: Imaging (including CT, MRI, ultrasound, and X-ray systems), Diagnostics (laboratory and point-of-care testing), Varian (cancer care and radiation therapy), and Advanced Therapies. Siemens Healthineers is particularly renowned for pioneering breakthroughs in medical imaging, having developed the world's first commercial PET/CT scanner and continuing to innovate in areas such as artificial intelligence, digital health solutions, and precision therapy. The company's commitment to research and development, with annual investments of approximately €1.5 billion, drives its mission to pioneer breakthroughs in healthcare for everyone, everywhere, sustainably.

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