Allosource Quality Engineer II in Centennial, Colorado
For more than 20 years, AlloSource's allografts have been the biologicsolutions our surgeon customers use to deliver better care to their patients.As one of the largest and most respected nonprofit tissue banks in the UnitedStates, AlloSource develops, processes and distributes over 200 types oflife-saving and life-enhancing allografts for use in a variety of medicalprocedures. Our commitment to honoring the gift of tissue donation motivatesus to develop innovative allografts and lead the way in cellular and tissuetheSummary:The Quality Engineer II is responsible for dealing with product and processrelated issues associated with sustaining engineering of current products,support process improvements and new product development.Essential Duties and Responsibilities:1. Support initiatives in all product manufacturing aspects: Qualityimprovement, Process Improvement and Documentation, and Quality Systemprocesse2. Develop sound understanding of products and focuses on ways to improvemanufacturing as well as identify and implement Quality improvements.3. Begin to take ownership of process changes with less direction frommanager.4. Support new product development.5. Signs-off on and reviews validation plans, protocols and reports.6. Becomes process expert and is liaison for operations personnel andprocess issues.7. Develop, track, and report quality system and production metrics.8. Utilize statistical techniques to compile and analyze data and realizeappropriate improvement initiatives.9. Collaborate with multiple departments to coordinate product changes andprocess improvements.10. Ownership, review and approval of controlled documents pertaining toareas of responsibility.11. Ownership of CAPA, NC, Change Control, and PHF documents.Requirements: Bachelor's degree in an engineering field 3 - 7 years' industry experience is required. Proficiency in Microsoft Applications, specifically ExcelPreferred Experience: 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 FDAregulated industry Previous training or experience with root cause analysis, lean six sixsigma, statistical techniques and/or quality systemsFor consideration you must apply online, submit a current resume and meetthe minimum requirements. All offers are contingent upon a backgroundcheck, drug screen and other contingencies may apply depending upon theposition. Candidates within a 50 mile radius of the hiring zip code mayreceive first consideration. If you require special accommodations, pleasecontact us at 720-873-0213.Equal Opportunity Employer/Veterans/DisabilityAlloSource uses E-Verify to confirm the employment eligibility of all newlyhired employees. To learn more about E-Verify, including your rights andresponsibilities, please visit www.dhs.gov/E-Verify.