Job Information
Axogen, Inc. Sr. Engineer, Quality Control in Vandalia, Ohio
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
Paid holidays, including floating holidays, to be used at your discretion
Employee Stock Purchase Plan
Referral incentive program
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 Sr. Engineer, Quality Control is a self-motivated individual that can provide test method optimization and qualification support through implementation of new processes, instrumentation, cost savings, and continuous improvements. The position will support the required action steps and compliance to meet Biologics requirements, while introducing lean processes into the laboratory. Position will ensure QC lab complies with applicable standards and regulations and partner with various APC and/or corporate departments to complete required testing, qualifications, and documentation.
Requirements of the Sr. Engineer, Quality Control
Bachelor's degree in chemistry/biology, or closely related field
Minimum 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, including data integrity and qualification
Leadership skills to support the analytical team (encompassing ELISA, pH, osmolality, KF, UV assay, eventually LC)
Problem solving using root cause methodologies including lean
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 or Black Belt certified
Responsibilities of the Sr. Engineer, Quality Control
The specific duties of the Sr. Engineer, Quality Control include but are not limited to:
- Partner with QC Lab Management on ongoing and new process improvements, efficiency improvements, and cross-training. This inclu