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

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/

JOB SUMMARY OF THE ENGINEER I, QUALITY CONTROL

The Quality Control Engineer I provides quality control engineering and support for QC Lab processes and procedural improvements along with implementation of new instrumentation and processes. The position will support required action steps and improvements to meet Biologics requirements. Position will ensure QC lab complies with applicable standards and regulations and partner with various APC and/or corporate departments to complete required projects and documentation. This position reports to Manager, Quality Control

REQUIREMENTS OF THE ENGINEER I, QUALITY CONTROL

• Bachelor’s degree in biomedical engineering, or similar field.
• 0-2 years’ experience in quality engineering, manufacturing, or quality control preferably in a Biologics or Pharmaceutical related field.
• ASQ Certified Quality Engineer preferred
• Understanding of instrument qualification requirements and execution.
• Ability to manage multiple priorities and collaborate with various teams.
• Applying statistics and software in data analysis (example Minitab)
• Familiar with Quality system regulations and requirements (examples 21 CFR part 600, 21 CFR Part 1271, 21 CFR Part 210/211)

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.

RESPONSIBILITIES OF THE ENGINEER I, QUALITY CONTROL

The specific duties of the Engineer I, Quality Control include but are not limited to:

• Confer with external and internal departments (example Operations, Corporate Quality, Engineering, Regulatory, Quality Assurance, Quality Systems) concerning various projects and actions required.
• Direct the completion of Qualification (IOPQ) and Re-Qualification requirements for QC Lab Instrumentation and new equipment.
• Develop protocols and oversee execution of the protocols, and final reports as related to qualification activities.
• Coordinate preventive maintenance for QC instrumentation along with periodic reviews. Maintain Blue Mountain requirements for QC.
• Assist with Periodic reviews of Computerized systems and address findings.
• Assist with change management activities and action items.
• Implement automation and new capital projects to optimize QC Lab Operations.
• Report to management on quality issues and investigations.
• Prepares reports and presentations by collecting, analyzing, and summarizing data, making recommendations.
• Maintain appropriate documentation in QMS system and maintain data integrity requirements in QC.
• Participate in Quality Control issue resolution (CAPA, Deviations, OOS Investigations) by applying root cause methodologies.
• Participate in FDA inspections and internal audits as required.
• Deploying proactive quality controls for consistent and predictable quality outcomes.
• Maintain metrics for monitoring system effectiveness.
• Provide functional support as needed for all team members.