Supplier Quality Engineer

onehealthineers; United States; On-site; USD 84,000 - 116,000; Full time

Job summary

Siemens Healthineers is seeking a Quality Engineer in the United States to lead supplier qualification, quality planning, and audits. This role involves working with engineering, purchasing, and suppliers to establish qualification criteria, manage supplier quality plans, and conduct first article inspections.

Strong ISO knowledge and Six Sigma experience are desirable. The position includes risk assessment, corrective actions, and collaboration with R&D to improve products and software

Qualifications

• Bachelor's degree in Electrical, Electronics, or Mechanical Engineering.
• 5 years of progressively responsible experience in a quality discipline or related field.
• Experience conducting quality-system and product audits at supplier facilities, domestically and internationally.
• Audit training from ASQ or ANSI-RAB NAP leading to ASQ-CQA or RAB certification.

Responsibilities

• Supplier qualification and quality planning with engineering and suppliers.
• Audit supplier sites to evaluate management systems and capabilities; create risk mitigation plans.
• Analyze nonconforming-material situations; determine root causes and corrective actions.
• Collaborate with R&D and customers to improve products and software solutions.
• Review design specs and develop material inspection plans in SAP.

Skills

Audits experience

Quality-system knowledge

Statistical analysis

MS Office/Excel

Education

Bachelor of Science in Electrical, Electronics, or Mechanical Engineering

ASQ-CQA or RAB certification

ASQ-CQE certification

ISO 13485 knowledge

ISO 9000 knowledge

Six Sigma training

Tools

Minitab

Microsoft Excel

Job description

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.
• Proficiency with Microsoft Office, particularly Excel; Minitab experience is an advantage.

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Who we are :

We are a team of more than 72,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways.

How we work:

When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual's potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world's most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

To find out more about Siemens Healthineers businesses, please visit our company page here .

The base pay range for this position is:

$84,200 - $115,775

Factors which may affect starting pay within this ra