The Quality Engineer II is responsible for dealing with product and process related issues associated with sustaining engineering of current products, support process improvements and new product development.
Essential Duties and Responsibilities:
- Support initiatives in all product manufacturing aspects: Quality improvement, Process Improvement and Documentation, and Quality System processes.
- Develop sound understanding of products and focuses on ways to improve manufacturing as well as identify and implement Quality improvements.
- Begin to take ownership of process changes with less direction from manager.
- Support new product development.
- Signs-off on and reviews validation plans, protocols and reports.
- Becomes process expert and is liaison for operations personnel and process issues.
- Develop, track, and report quality system and production metrics.
- Utilize statistical techniques to compile and analyze data and realize appropriate improvement initiatives.
- Collaborate with multiple departments to coordinate product changes and process improvements.
- Ownership, review and approval of controlled documents pertaining to areas of responsibility.
- Ownership of CAPA, NC, Change Control, and PHF documents.
- Bachelor’s degree in an engineering or technical field
- 3 - 7 years’ industry experience is required.
- Proficiency in Microsoft Applications, specifically Excel
- Master’s degree in an engineering or technical field
- 5+ years’ industry experience
- Proficiency in Minitab
- Previous experience at tissue bank, medical device or other FDA regulated industry
- Previous training or experience with root cause analysis, lean six six sigma, statistical techniques and/or quality systems
For consideration you must apply online, submit a current resume and meet the minimum requirements. All offers are contingent upon a background check, drug screen and other contingencies may apply depending upon the position. Candidates within a 50 mile radius of the hiring zip code may receive first consideration. If you require special accommodations, please contact us at 720-873-0213.
Equal Opportunity Employer/Veterans/Disability
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