19 days old

Senior Quality Supplier Engineer

Mishawaka, IN 46544
Senior Quality Supplier Engineer

+ Mishawaka, Indiana

+ Quality Management

+ 247825

Siemens Healthineers

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**Job Description**

**Organization:** Siemens Healthineers

**Business Unit:** Point of Care

**Requisition Number:** 247825

**Primary Location:** United States-Indiana-Mishawaka

**Assignment Category:** Full-time regular

**Experience Level:** Mid level

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

**Travel Required:** No

**Job Description:**

Classification: Supplier Quality Engineer - Immunoassay

Supplier Quality Engineers are primarily responsible for all
quality related aspects of raw material entering the plant. This includes day
to day support of the manufacturing line, problems that occur, and
non-conformance that may be generated. The role works closely with the
manufacturing and engineering teams to assure compliance with all appropriate
regulations and specifications. Prompt responsiveness is a requirement to avoid

**Duties and Responsibilities:**

+ Support design transfer of newproduction coming into the facility, including raw material specificationdevelopment, supplier audits and supplier monitoring/qualification, and developmentof incoming inspection processes

+ Interact with multiple functionsacross sites including Engineering, Manufacturing, Technical Operations,and Regulatory Compliance

+ Become Subject Matter Experts onall aspects of each raw material

+ Lead the MRB process to resolvematerial non-conformances

+ Write or revise necessaryproduction-controlled documents as needed

+ Participate as a manufacturingSubject Matter Expert on any process change to assure that properdocumentation, validations, and/or qualifications are performed

+ Responsible for assuring promptcompletion of process related quality notifications and tracking/reportingall necessary tasks to assure completion. Serve as Quality Notificationcoordinator

+ Participate in root cause investigations.

+ Participate in CAPA Review Board asrequired

+ Participate in Validation ReviewBoard as required

+ Prepare for FDA inspections andregistrar audits

+ Able to effectively communicatewith internal and external customers

**RequiredKnowledge/Skills, Education, and Experience:**

+ PreferredBachelors Science Industrial Engineering

+ Alsoacceptable with equivalent experience: Other engineering or science degree

+ Seekingimmunoassay experience with microfluidics, protein chemistry, and ELISA

+ 10years experience in the medical device/pharmaceutical industry withbackground in supplier quality. Knowledgeable of all industry regulationsand requirements

+ ProcessControl Technology experience is helpful

+ Statisticalknowledge and Design of Experiments experience

+ Strongprocedure development/technical writing skills

+ ValueStream Mapping/Lean experience is helpful

+ Strongcommunications background, both written and verbal

+ ASQCCertifications helpful

**Other characteristics of the successful candidate:**

organized, detail-oriented


to work independently

analytical, communication, writing, and problem-solving skills

and influential in his/her interactions in team-based assignments

Able to work well with personnel from
different departments, and experience levels

Ability for potential international
travel from time to time


**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 .


Posted: 2019-09-04 Expires: 2019-10-04

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Senior Quality Supplier Engineer

Mishawaka, IN 46544

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