Quality Engineer 4 Job in Knoxville 37901, Tennessee Us

We're Siemens, a global innovation company helping the needs of businesses, communities and employees right here in the US. From improving security at airports, to helping healthcare professionals make more accurate diagnoses of the heart, to reducing delivery time for forwarded mail and beyond, we're achieving the unexpected all because of our employees. Which is why we offer a work culture where ideas are free to fly, diversity programs that capture the strengths of thought rather than ethnicity, and mentoring and training programs that can take careers to new heights. And that's pretty inspiring.

Because when you and 70,000 diverse minds innovate together, you can change the world. Imagine that.

automation control • building technologies • energy power • financial services • hearing solutions
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Siemens is an equal opportunity employer encouraging diversity in the workplace.

Quality Engineer 4


Company: Siemens Medical Solutions USA, Inc.

Division: SMS - Molecular Imaging

Location: TN - Knoxville

Req ID: 107852

Position Title: Quality Engineer 4

Experience Level: Mid Level

Education Required: Bachelors Degree

Travel Required: Yes

Company Description:
We are one of the largest global suppliers of healthcare equipment, renowned for innovative products, services and solutions including diagnostic imaging systems, therapy equipment for treatment and electromedicine and IT solutions to optimize workflow and increase efficiency in the healthcare industry. 

Siemens is an Equal Opportunity Employer encouraging diversity in the workplace.

Job Description:
We are currently looking for a Regional Quality Systems Manager in Knoxville, TN. Please note: This position is considered a functional manager with no direct reports. This position reports to the Senior Manager, QA Operations and has primary responsibility for: Supporting corporate efforts for implementation and harmonization of quality systems at all manufacturing sites and developing and re-engineering quality systems so that they meet the requirements 21 CFR 212.

Regional manufacturing site responsibilities will include:

- Direct interaction with all quality related matters at assigned manufacturing sites
- Routine site visits
- Internal audit assistance
- Training for quality related practices
- Assistance with writing sterility OOS investigations, deviations, non-conformances, etc.
- Prepare monthly quality metric reports for monthly quality council reviews

Qualified candidates must have: Bachelor of Science degree; 10 to 15 years of experience in the pharmaceutical industry and be willing to travel 20-40%. Additional experience with PET drugs would be beneficial. The ideal candidate's experience must include a proven track record for development, implementation, and management of the vast majority of the following key quality systems, methods, and processes:
- Exception Management (Complaint, Nonconformity, OOS, Planned Variance, etc.)
- Change Management
- Root Cause Analysis
- Metrics and Trending
- Annual Product Review
- Batch Records
- Calibration
- Packaging and Labeling
- Procedures, Forms, etc.)
- Supplier Quality
- Control of Components
- Validation
- Training

Additional experience in the following quality systems, methods, and processes would be beneficial:
- Sterility Assurance / Microbiological Control
- Pharmaceutical Manufacturing/Compounding
- Analytical Methods
- Facilities, Equipment, and Controlled Environmental Areas
- Cleaning Validation
- Six Sigma/Lean Manufacturing

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Additional Information:


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