Supplier Quality Engineer

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions.

Core Responsibilities Supplier Qualification and Quality Planning The role requires the candidate to:

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 The primary requirements are:

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 The position may be particularly suitable for candidates seeking to develop a career with Siemens Healthineers who have the following background:

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.

Pro…