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About the Role

As the site's primary quality engineering resource, you will have the opportunity to contribute to important engineering decisions and directly support manufacturing operations, incoming inspection, supplier quality, quality systems, and continuous improvement activities within an ISO 13485:2016 -compliant manufacturing environment. Working closely with Supply Chain, Engineering, Regulatory Affairs, IT, and other cross-functional teams, the Quality Engineer will help develop, implement, and sustain scalable quality practices that ensure product quality, process effectiveness, regulatory compliance, and operational excellence.

Responsibilities

Serve as a key quality engineering resource across quality systems, and operational excellence initiatives.
Define, implement, maintain, and continuously improve quality system processes, procedures, work instructions, and other related controlled documentation to support Austin operations and ISO 13485:2016 compliance.
Support manufacturing operations by ensuring products, processes, and quality controls meet established specifications, regulatory requirements, and customer expectations.
Investigate, document, and support the timely closure of nonconforming materials, components, processes, and finished goods while partnering with Operations, Engineering, Supply Chain, and other stakeholders to drive timely resolution.
Lead and support root cause investigations, containment actions, corrective and preventive actions (CAPA), and recurrence prevention efforts using structured problem-solving methodologies.
Analyze quality system data to identify trends, mitigate risks, and drive data-based improvements.
Establish, monitor, and report key quality performance indicators, including yield, defect trends, supplier performance, inspection effectiveness, calibration compliance, and issue closure metrics.
Support new product introductions, manufacturing readiness activities, process changes, equipment qualification, risk assessments, process validation, and production builds as needed.
Participate as needed in internal audits, management reviews, document control activities, and other quality system processes to ensure site compliance and audit readiness.
Partner closely with Operations, Manufacturing Engineering, Supply Chain, Product Quality, Supplier Quality, Quality Systems, and site leadership to resolve quality issues, strengthen process controls, and enhance customer satisfaction.
Apply Lean, Six Sigma, statistical methods, and continuous improvement tools to reduce variation, improve yield, lower the cost of poor quality, and drive operational excellence.

Requirements

Bachelor's degree in Industrial, Mechanical, Manufacturing, Quality, or a related engineering discipline, with 2+ years of experience in a quality, manufacturing, or process engineering role.
Experience supporting manufacturing operations, establishing Quality Management Systems (QMS), quality investigations, and continuous improvement initiatives.
Working knowledge of ISO 13485:2016 or similar quality management system requirements.
Experience using structured problem-solving and root cause analysis methodologies to investigate and resolve quality issues.
Strong analytical skills with the ability to interpret data, identify trends, and drive effective corrective actions.

Skills

ISO 13485:2016
Quality Management System (QMS)
Lean Manufacturing
Six Sigma
Statistical Process Control (SPC)
Failure Mode and Effects Analysis (FMEA)
8D
SAP
ERP systems
eQMS
Quality reporting
Quality analytics tools
ASQ Certified Quality Engineer (CQE)
Six Sigma Green Belt

Location

Austin, Texas

Work Type

Onsite
Full-time

Experience Level

2+ years of experience

Education Level

Bachelor's degree in Industrial, Mechanical, Manufacturing, Quality, or a related engineering discipline

Salary/Compensations

$96,440 - $132,605

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

About the Company

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.
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.

Equal Opportunity

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.
Applicants and employees are protected under Federal law from discrimination.
Siemens Healthineers is committed to equal employment opportunity. As part of this commitment, we will ensure that persons with disabilities are provided reasonable accommodations.
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.