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Axogen

Specializes in peripheral nerve repair devices

Senior Quality Engineer

Regulatory & Quality (Life Sciences)Posted on Nov 11
Full-timeVandalia, OH, USA

About the Job

Requirements

  • A minimum Bachelor of Science degree in Biomedical Engineering, Mechanical Engineering, or Engineering Technology is required.
  • Knowledge of lean/progressive manufacturing and quality disciplines is required.
  • A fundamental understanding of design controls, project management, and basic manufacturing practices and processes is required.
  • A minimum of 5 years of experience in a Quality Engineering or Quality Assurance role in medical device or pharmaceutical manufacturing is required.
  • Strong project management skills are required.
  • Knowledge of statistical sampling and analysis is required.
  • Proficiency with the Microsoft Office Suite, including Microsoft Visio and Microsoft Project, is required.
  • Ability to limit gauge design for dimensional verification is required.
  • Ability to solve problems using root cause methodologies, such as DMAIC, is required.
  • Ability to apply statistics and software in data analysis, such as Minitab, is required.
  • Knowledge of failure modes and effects analysis (FMEA) is required.
  • Experience working with suppliers to design inspection systems and resolve quality issues is required.
  • Knowledge of quality system regulations and requirements, including 21 CFR Part 820, 21 CFR Part 1271, 21 CFR Parts 210 and 211, ISO 13485, ISO 9001, and ISO 14971, is required.
  • Experience with geometric dimensioning and tolerancing (GD&T) is required.
  • Ability to travel up to 30% is required.

Responsibilities

  • Confer with external and internal departments, including Product Development, Clinical, Marketing, Sales, and Operations, about product design to ensure user needs are met.
  • Evaluate product designs for manufacturability and recommend design process adjustments and quality improvements.
  • Engage in the selection, development, qualification, and validation of manufacturing tools, fixtures, machinery, and equipment.
  • Lead and participate in risk management activities.
  • Lead quality issue resolution using root cause methodologies.
  • Ensure effective design control and transfer to production.
  • Lead quality planning for new product development projects, including verification and validation plans and reliability strategies.
  • Lead quality planning for facility development, including verification and validation plans and reliability strategies.
  • Lead quality planning for new and existing processes, including verification and validation plans and reliability strategies.
  • Investigate manufacturing processes to reduce non-conformance and optimize inspection.
  • Determine quality improvement parameters by identifying statistical methods relevant to manufacturing processes.
  • Prepare reports and presentations by collecting, analyzing, and summarizing data and making recommendations.
  • Maintain professional and technical knowledge by attending educational workshops, reviewing professional publications, establishing professional networks, benchmarking state-of-the-art practices, and participating in professional societies.
  • Collaborate with supply chain partners to assure product quality.
  • Confer with purchasing and logistics to maintain the supplier management program.
  • Design and implement inspection methods, equipment, acceptance criteria, and sampling plans.
  • Initiate or assist with cost reductions in product inspections.
  • Provide validation, sampling, and statistical analysis support to other organizational functions.
  • Perform First Article Inspections to ensure manufacturing process capability.
  • Ensure compliance with CGMP, QSR, ISO 13485, MDD, and other applicable regulations and standards.
  • Participate in FDA inspections, ISO certification activities, surveillance audits, and customer audits.
  • Deploy proactive quality controls to achieve consistent and predictable quality outcomes.
  • Establish and implement metrics to monitor system effectiveness.
  • Report quality issues, trends, and losses to management.
  • Provide functional support to team members as needed.
  • Direct staff as needed.

Desired Qualifications

  • ASQ Certified Quality Engineer credential is desirable but not required.
  • Lead auditor certification is desirable but not required.
  • Six Sigma Black Belt is desirable but not required.

About the Company

Axogen

Specializes in peripheral nerve repair devices

AxoGen develops and sells surgical solutions for peripheral nerve repair. Its core products include Avance Nerve Graft, a processed human nerve allograft that bridges nerve gaps without a second surgical site, and Axoguard devices for nerve coaptation, protection, and neuroma reduction. The products are distributed directly to hospitals and surgical centers, targeting plastic, hand, and oral/maxillofacial surgeons. The goal is to improve nerve repair outcomes and grow a sustainable business in the U.S. nerve repair market by offering clinically proven, FDA-cleared tissue grafts and devices.

Company size
501-1,000
Company stage
IPO
Headquarters
Alachua, FL
Founded
2002

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