Merakey Jobs

Axogen is committed to building and maintaining a strong and gratifying company culture that fosters professional growth. Our hands-on and personal approach makes transitioning to a new job a seamless and enjoyable process. Most benefits are effective on day one! Axogen is an equal opportunity employer and does not discriminate against applicants on the basis of race, color, creed, religion, ancestry, age, sex, marital status, national origin, disability or veteran status. Why you'll love working at Axogen: * Friendly, open, and fun team culture that values unique perspectives * Company-wide dedication to profoundly impacting patients' lives * Comprehensive, high-quality benefits package effective on date of hire * Educational assistance available for all employees * Matching 401(k) retirement plan * Flexible working hours * Paid holidays, including floating holidays, to be used at your discretion * Employee Stock Purchase Plan * Referral incentive program If you want to see how you can impact lives at Axogen, take a look at these inspiring patient stories: https://www.axogeninc.com/patient-stories/ Axogen Mission and Business Purpose Our business purpose is to restore health and improve quality of life by making restoration of peripheral nerve function an expected standard of care. We aim to lead the markets we serve by always requiring the solutions we offer patients and caregivers provide an improved benefit-to-risk profile as compared to existing standards of care. To ensure we deliver improved benefit-to-risk solutions, we will guide and expect the market and design requirement specifications underlying our engineering, business development, and clinical research activities, objectively target advancements in standards of care. Job Summary of the Sr. Engineer, Quality Control The Quality Control Sr. Engineer (Scientist) provides test method and qualification support along with implementation of new processes, instrumentation, cost savings, and continuous improvements. The position will support the required action steps and process improvements to meet Biologics requirements. The position will ensure QC lab complies with applicable standards and regulations and partner with various APC and/or corporate departments to complete required testing and documentation. Requirements of the Sr. Engineer, Quality Control * Bachelor's degree in chemistry/biology, or closely related field * 5+ years' experience in Quality Control laboratory, R&D Laboratory, or Quality Engineering preferably in a Biologics or Pharmaceutical related field. * Understanding of quality control instrumentation, troubleshooting, and testing methods including data integrity and qualification requirements. Specific experience with ELISA based assays and software preferred. * Problem solving using root cause methodologies including lean principles. * Applying statistics and software in data analysis (example Minitab) * Quality system regulations and requirements (examples 21 CFR part 600, 21 CFR Part 1271, 21 CFR Part 210/211) * Six Sigma Green/Black Belt preferred Responsibilities of the Sr. Engineer, Quality Control The specific duties of theSr. Engineer, Quality Control include but are not limited to: * Drive completion of OOS investigations and deviations for QC and work with QS to improve investigation module and reports related to all testing completed at APC or contract labs. Partner with Corporate Quality as required. * Develop protocols for projects such as method improvements, oversee execution of the protocols, author final reports and manage approval and implementation. * Partner with QC Lab Management on ongoing and new process improvements,Apply here: https://www.aplitrak.com/?adid=YmJnZW5lcmljLjAxNTg0LjEwNTA4QGF4b2dlbmluY2NvbXAuYXBsaXRyYWsuY29t