Quality Engineer 2

Job Description

Organization: Siemens Healthineers
Business Unit: Laboratory Diagnostics
Requisition Number: 241138
Primary Location: United States-New Jersey-Flanders
Assignment Category: Full-time regular
Experience Level: Mid level
Education Required Level: Bachelor's Degree
Travel Required: 10%

Job Description:

Position Overview


The Quality Engineer 2 will assist in Nonconforming Material activities at the Flanders Facility, responsibilities including the containment, disposition and trending of non-conformances. In this role, he/she will interface with Procurement, R&D, Engineering and Operations to ensure that nonconforming material is controlled and dispositioned in accordance with approved processes and data.



·        Support established production processes, by participating at daily production and weekly quality meetings.

·        Investigate, and disposition nonconforming material via MRB processes utilizing the SAP Quality Module.

·        Gathering and analysis of quality data for trending purposes using software tools such as MiniTab and Microsoft Excel.

·        Leading and participating at cross functional material review boards (MRB).

·        Determination of root cause analysis and implementation of corrective action for process related concerns.

·        Analyze failure, corrective and preventive action to respond to customer complaints.

·        Initiate, execute, review and approve changes via change control process

·        Assist Quality manager in establishing, implementing and maintaining the quality management system

·        Provide support by performing internal audits and participating in external audits

·        Support test method validation and gage R&R studies


Required Knowledge/Skills, Education, and Experience


·        Bachelor’s degree in engineering or science, required.

·        Required experience: 3-5 years successful experience in a medical device/biotech industry in process/manufacturing engineering or quality assurance with focus on deviations and nonconforming material control/dispositioning within a manufacturing environment.

·        Working knowledge of ISO 13485 and FDA Quality System Regulations, required.

·        Flexibility to travel (approximately 10% of the time, but as needed)

·        Strong written, computer and verbal skills with an extensive knowledge of the Microsoft Office Applications, especially Excel. SAP experience, strongly preferred.


Preferred Knowledge/Skills, Education, and Experience



·        Mechanical, electrical or biomedical engineering background.

·        ISO Lead auditor certification from a recognized 3rd party.

·        Minitab or Statistical analysis Tools experience.

·        Six Sigma green or black belt certification.

·        Certified Quality Engineer (CQE)/Certified Quality Auditor (CQA).

·        Direct ISO 13485/FDA inspection experience.


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.

Pay Transparency Non-Discrimination Provision
Siemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more, Click here.

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