1+ months

Quality Engineer 4

Issaquah, WA
**Quality Engineer 4**

Locations:Issaquah, Washington

Job Family: Quality Management


English (US)

**Job Description**

**Division:** Siemens Healthineers

**Business Unit:** Ultrasound

**Requisition Number:** 222765

**Primary Location:** United States-Washington-Issaquah

**Assignment Category:** Full-time regular

**Experience Level:** Senior level

**Education Required Level:** Bachelor's Degree

**Travel Required:** 5%

**Division Description:**


**Job Description:**

Siemens Ultrasound is seeking an energetic and highly motivated Sr. Quality Engineer who will be responsible for supporting the Product Development Process as a member of the Quality group. This position is responsible for ensuring project Quality including reliability and compliant design control practices.

**Essential Functions:**

Partner with cross-functional leadership to ensure all aspects of Product Development are performed in conformance to the quality management system and regulatory requirements

Accountable for Quality of Ultrasound products, and execution of continuous improvement for projects, supplier Quality initiatives and process improvement/development project(s).

Engage and understand the industry environment for Ultrasound best practices and be able to execute and implement those requirements as the business dictates. Specifically these areas include Engineering (process, material and product design), Quality (Six Sigma, DOE, Validation, etc.) and Documentation (Operating procedures, Contracts, Agreements, Training, etc.).

Review product lifecycle documentation against product and process requirements using specifications, materials, tools, techniques, and methodologies in accordance with applicable procedures and standards

Identify, report and follow-up on process adherence issues

Improve customer satisfaction through Quality initiatives and continuous process improvements

Ensure process harmonization in a global environment

Update existing processes, and develop new ones as required

Train the organization on new and updated processes

Execute mock-audits, report findings and follow up on issues


Working knowledge of medical device requirements including: Quality System Regulation (QSR 21 CFR 820), Canadian Medical Device Regulations, IEC 62304, ISO 13485, ISO 14971 and IEC 62366

5+ years Quality Engineering experience in a GMP environment or highly regulated industry

Bachelor's Degree in Electrical Engineering, Computer Engineering or equivalent technical Degree; or equivalent combination of education and experience

Demonstrated ability to handle highly confidential information appropriately.

Excellent analytical skills

Quality/Reliability Engineering expertise

High level of initiative with ability to self-manage

Strong interpersonal skills with ability to work independently and as part of a team

ASQ certification and or ISO 13485 Lead Auditor certification a plus


**Equal Employment Opportunity Statement**

Siemens 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, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, protected veteran or military status, and other categories protected by federal, state or local law.

**EEO is the Law**

Applicants and employees are protected under Federal law from discrimination. To learn more, Click here at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm .

**Pay Transparency Non-Discrimination Provision**

Siemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more, Click here at https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf .


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Quality Engineer 4

Issaquah, WA

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