Quality Engineer 4

Plainfield, Indiana
04 Oct 2016
24 Nov 2016
Oil and Gas
Contract Type
Full Time
Division Healthineers
Job Type Regular

Business Unit Healthineers - HC_Only Select if Business Area is
Job Time Full-Time

Functional Area ENG - Engineering
Experience Level Mid Level

Req ID 155452
Required Education Bachelors Degree or equivalent experience

Location IN - Plainfield
Required Travel 30%

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 world's 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/healthcare

Job Description
HC - Quality Engineer 4
Position Overview

Responsible for execution of complex project/program plan. Responsible for delivery of complex project/program. Performs project/program management activities (defining scheduling, budget, risk, change, opportunity and resource management activities). Performs technical review of product and process design and documentation. Executes continuous improvement plan. Needs to manage external or internal consultants.


•Quality Planning - Role will develop and implement Quality Plans within the Transportation Processes to execute continuous improvement projects, supplier development initiatives and any compliance improvement/development project(s).  
•Purchasing and Supplier Controls - Role will work directly with procurement and transportation group to manage and develop suppliers, including assisting with material, supplier and process changes.
•Regulatory Requirements - Role will be expected to understand the regulatory environment and have the ability to communicate and manage the expectations of the geographical regulatory environment in which Siemens Transportation processes are engaged in.  GDP, cGMP, etc.
•Industry Best Practices - Role will be required to engage, understand the industry environment for Transportation best practices and be able to execute and implement those requirements as the business dictates.  Specifically these areas will include Engineering (process, material and product design), Quality (Six Sigma, DOE, Validation, etc.) and Documentation (Operating procedures, Contracts, Agreements, Training, etc.).  
•Project Management - Role will be required to execute and deliver complex projects/deliverables.  This will require management of key activities (scheduling, budget, risk, change control, resource management) across multiple departments/roles and both internal and external resources. Track and report on key metrics, goals and objectives, communicating and maintaining progress to key stakeholders.
•Engineering - Role will be expected to support effective, systematic problem solving and investigational skills as well as applying engineering methodology examples include:
•DOE - Design of Experiments
•CAPA - Corrective and Preventative Action process and system understanding and   knowledge.
•Six Sigma - Execution and fundamental use of Six Sigma tools/methodology.
•Design Control - working with cross functional groups in ensuring design control requirements are met/maintained.
•Auditing - Role will be required to support auditing activities for both internal and external audits.  This will include development of audit work plans, audit schedule(s), execution of audits per regulatory and company requirements.  This role will also be expected to identify issues, areas for improvement and recommended actions as required to ensure regulatory and business requirements are met, including continuous improvement activities.
•Validation - Role will be expected to develop and execute validation and qualification activities which will require evaluation of risk (FEMA), developing protocols, training, statistical analysis and technical report writing

Required Knowledge/Skills, Education, and Experience

• Understanding of FDA Quality System Regulation for medical devices; specifically risk management, design controls, nonconformance, CAPA, and design and process validation
• Complex project management experience
• Strong communication and organization skills
• Leadership experience in a matrix organization
• Bachelor's degree in Engineering or related scientific degree

Preferred Knowledge/Skills, Education, and Experience

The knowledge/skills, education, and experiences are preferred but NOT required to be considered for this position.
Process Validation
IQ, OQ, PQ Creation and
Review Project Protocol
Project Report Creation and Review
Change Control Creation and Review
Risk Management (FMEA) Experience
Statistical Sampling Plan Creation and Review
SOP Creation and Review
21 CFR Part 820 (QSR) and ISO 13485 Experience

Siemens encourages qualified long-term unemployed individuals to apply for open positions.

Offer of employment with Siemens is conditioned upon the successful completion of a background check and drug screen, subject to applicable laws and regulations.

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, disability status, 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. Click here to learn more.

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