Supplier Quality Engineer

563d Siemens Medical Solutions USA, Inc.; United States; On-site; USD 84,000 - 116,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Life insurance

Disability insurance

Paid parking/public transportation

Paid time off

Paid sick time

Job summary

Siemens Healthineers is seeking a Quality Engineer focused on supplier qualification, quality planning, audits, and corrective actions to ensure supplier conformity and robust processes. You will collaborate with Engineering, Purchasing, and suppliers to define qualification criteria, establish supplier quality plans, and review deviations with proper approvals.

The role also includes conducting supplier-site and process audits, developing supplier KPIs, and driving corrective-action plans

Qualifications

• BS in Electrical, Electronics, or Mechanical Engineering.
• 5 years of progressively responsible experience in a quality discipline or related field.
• Experience conducting supplier quality audits domestically and internationally.
• Audit training from ASQ or ANSI-RAB NAP; ASQ-CQA or RAB certification.
• ASQ-CQE certification
• Knowledge of ISO 13485 and ISO 9000.
• Training in Six Sigma, SPC, Gage R&R, FMEA, Poka-Yoke.
• Proficiency with Microsoft Office, especially Excel; Minitab experience preferred.

Responsibilities

• Collaborate with Engineering, Purchasing, and suppliers to establish new-product qualification criteria and create supplier quality plans and first article inspections.
• Collaborate to ensure technical requirements are clearly understood and deviations receive approval and documentation.
• Approve and manage direct and indirect quality-relevant material suppliers and ensure material conformance.
• Review design specs and develop material inspection plans in SAP for incoming inspection personnel; guide inspection staff.
• Conduct supplier-site audits to evaluate management systems and capabilities; identify gaps and create risk-analysis and mitigation plans.
• Develop and maintain supplier performance KPIs and verify corrective actions are effective.
• Perform supplier quality management and process audits at domestic or international sites and drive CAPAs.
• Analyze nonconforming materials, determine root causes, and establish corrective-action plans.
• Evaluate supplier responses to corrective actions and use basic statistics to assess process control.
• Support customers during external visits and share knowledge with R&D to improve products and software solutions.

Skills

Quality engineering

Supplier audits

Root cause analysis

Statistical methods

ISO 13485

Minitab

Excel

SAP

Education

BS in Electrical, Electronics, or Mechanical Engineering

Tools

SAP

Excel

Minitab

Job description

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.

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

The base pay range for this position is: $84,200 - $115,775.

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.

Company culture

We are part of an incredible community of scientists, clinicians, developers, researchers, professionals, and skilled specialists pushing the boundaries of what’s possible, to improve people’s lives around the world. We embrace a culture of inclusivity in which the power and potential of every individual can be unleashed. We spark ideas that lead to positive impact and continued success.

Equal Employment Opportunity Statement: Siemens Healthineers is an Equal Opportunity and affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law. EEO is the Law: Applicants and employees are protected under Federal law from discrimination.

Export Control: “A successful candidate must be able to work with controlled technology in accordance with US export control law.” “It is Siemens Healthineers’ policy to comply fully and completely with all United States export control laws and regulations, including those implemented by the Department of Commerce through the Export Administration Regulations (EAR), by the Department of State through the International Traffic in Arms Regulations (ITAR), and by the Treasury Department through the Office of Foreign Assets Control (OFAC) sanctions regulations.”