Sr. Engineer, Quality Control

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 youll love working atAxogen:

• Friendly openandfunteam culturethat values uniqueperspectives
• Company-wide dedicationto profoundly impacting patients lives
• Comprehensive high-quality benefitspackage effective on date of hire
• Educationalassistanceavailable for all employees
• Matching 401(k)retirementplan
• Paid holidaysincluding floating holidaysto 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 theSr. 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 theSr. Engineer Quality Control

• Bachelors 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 includes any validation addendums or improvements and optimization of systems.
• Develop protocols for projects such as method improvements oversee execution of the protocols author final reports and manage approval and implementation.
• Direct the completion of Qualification and Re-Qualification requirements for QC Lab Instrumentation and new equipment. Contribute to validation planning for new and existing processes instrumentation or methods.
• Drive completion of OOS investigations deviations and change control 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.
• Confer with external and internal departments (example Operations Corporate Quality Engineering Regulatory Quality Assurance Quality Systems) concerning various projects and actions required.
• Lead and participate in BLA support including PAI action steps audit actions document/procedural updates MOC creation/execution CAPAs.
• Define and implement automation and new capital projects to optimize QC Lab
• Prepares reports and presentations by collecting analyzing and summarizing data making
• Provide statistical data support for various Lean projects within Develop any Project Charters required for Lab Improvement/cost savings projects.
• Lead Quality Control issue resolution by applying root cause
• Participate in FDA inspections and internal
• Deploying proactive quality controls for consistent and predictable quality
• Establish and track metrics for monitoring laboratory
• Report to management on quality issues and
• Provide functional support as needed for all team

Location

913 Industrial Drive Place Vandalia OH 45377

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Benefits/Compensation

Axogen follows healthcare system guidelines with respect to credentialing vaccinations and other employment/compliance related requirements as well as CDC guidance. Axogen reserves the right to amend its policies from time to time in its sole discretion.