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Quality Engineer II
| Company | Becton Dickinson |
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| Location | Lafayette, CO, USA |
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| Salary | $73300 – $121000 |
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| Type | Full-Time |
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| Degrees | Bachelor’s |
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| Experience Level | Mid Level |
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Requirements
- B.S. in Engineering, Engineering Technology, Science a minimum.
- Minimum 3 years of experience with FDA regulated industry, preferably on product development programs.
Responsibilities
- Participates on Project Team as Quality Representative. Ensures that principals of Design Control are applied to Product and Process Changes and New Product Development.
- Lead Quality Initiatives for Target Temperature Management products that include the entire product life cycle (Development, Commercialization and Post Market Surveillance).
- Creates, reviews, and approves Risk Management File documents such as: Risk Management Report, Hazard Analysis, Risk Benefit Analysis and FMEA’s.
- Leadership in failure investigations, corrective and preventive actions plan and continuous improvement projects using methodologies as Six Sigma/Lean Six Sigma.
- Creates, reviews, and approves Design Specifications, Design Verification Protocols and reports, Process and Product Validations, Software Validation documents and Test Method Validations.
- Creates, reviews and Improves Quality System Documents (CAPA, Audits, Risk Management, Design controls).
- Creates and reviews Product Documents.
- Participates in Internal, External and Supplier Quality Audits.
- Participates and has membership in trade and/or professional organizations to ensure that state-of-the-art industry standards are communicated into the division in an efficient, timely, and accurate manner.
- Interfaces with manufacturing facility or other Division Facilities.
- Travels as required by the above duties and responsibilities.
Preferred Qualifications
- American Society of Quality (ASQ) certification (CQE, CRE,) preferred
- Lean Six Sigma green belt preferred
