18 days old

Sr E/M Inspector

Mount Olive Township, NJ 07836
**Sr E/M Inspector**

Locations:Flanders, New Jersey

Job Family: Manufacturing


English (US)

**Job Description**

**Division:** Siemens Healthineers

**Business Unit:** Laboratory Diagnostics

**Requisition Number:** 218519

**Primary Location:** United States-New Jersey-Flanders

**Assignment Category:** Full-time regular

**Experience Level:** Mid level

**Education Required Level:** Associate's Degree / College Diploma

**Travel Required:** No

**Division Description:**

Siemens is a global technology powerhouse that has stood for engineering excellence, innovation, quality, reliability and internationality for more than 165 years. As a global technology company, Siemens is rigorously leveraging the advantages that this setup provides. To tap business opportunities in both new and established markets, the Company is organized in nine Divisions: Power and Gas, Wind Power and Renewables, Energy Management, Building Technologies, Mobility, Digital Factory, Process Industries and Drives, Healthineers and Financial Services.

With 45,000 employees Siemens Healthineers is one of the worlds largest suppliers of technology to the healthcare industry and a leader in medical imaging, laboratory diagnostics and healthcare IT. All supported by a comprehensive portfolio of clinical consulting, training, and services available across the globe and tailored to customers needs. So that more people can have a life that is longer, richer, and more filled with happiness.

For more information, please visit: http://www.usa.siemens.com/healthineers

**Job Description:**

**Siemens US Talent Acquisition**

_Job Description Template_

**Position Overview**

Responsible for supporting the Quality Engineering needs of commercial, R&D and clinical operations. Responsible for the establishment and maintenance of quality assurance standards, that adheres to cGMP, QSR and ISO regulations.


+ Support the daily commercial manufacturing activities and work withManufacturing Engineers to resolve line issues and implement corrective actions.

+ Provide technical support for incoming inspection activities and lot release testing activities

+ Identify and assist with implementation of corrective and preventative actions related to production or Quality System improvements

+ Lead investigation and drive closure of non-conforming material (QNs) in a timely manner as needed.

+ Work with Supply Chain to resolve supplier quality issues

+ Develop and revise Quality System procedures (SOPs and WIs).

+ Develop test methods and lead test method validation activities.

+ Develop/write protocols and coordinate the testing for validation activities, component qualification activities, IQ/OQs, gauge R&R studiesas necessary

+ Providetraining and/or technical guidance to QA Technicians and production staff as required.

+ Provide statistical data analysis and interpretationsupport for investigations, specification setting activities, and test protocols

+ Participate in inspections for FDA, ISO, and other regulatory agencies

+ Support company goals and objectives, policies and procedures, QSR, and FDA regulations.

+ Maintain accurate records/documentation related to quality, test results, and special projects.

+ Adhere to general safety rules, manufacturing procedures, company policies and procedures, QSR, Good Manufacturing Practices, and FDA regulations.

**Required Knowledge/Skills, Education, and Experience**

+ Associate's or Bachelor's degree preferred in Engineering/Life Sciences and a minimum of 5 years medical device experience.

+ Experience with quality system elements pertaining to combination products (drug/device) and QSR, cGMP and ISO 13485familiarity is strongly preferred.

**Preferred Knowledge/Skills, Education, and Experience**

+ Strong written and verbal communication skills and attention to detail.

+ Must work independently and have the ability to mentor junior Incoming inspectors

+ Self-Starting, detail oriented, quick learner, creative and analytical.

+ Capable of understanding and analyzing complex engineering problems.


**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 .


  • Engineering
  • Financial Services
  • Legal
  • Manufacturing / Production
  • Healthcare

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Mount Olive Township, NJ 07836

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