Quality Manager

Research & Development · Columbus, Ohio
Department Research & Development
Employment Type Full-Time
Minimum Experience Manager/Supervisor

General Description:

 

Apply your creativity and passion to develop innovative medical devices that can greatly improve patients’ lives. We take pride in a truly entrepreneurial environment, unique technical challenges and a collaborative culture. We welcome you to explore Avation and be part of a talented team and an exciting company.

 

Key Responsibilities:

 

  • Lead Quality function for development of innovative medical devices and systems
  • Establish and improve Avation quality management system and operating procedures
  • Responsible for product quality, proper documentation and continuous improvement
  • Lead supplier quality, incoming inspection methods and process validation (IQ/OQ/PQ)
  • Develop manufacturing process documentation including device history records
  • Ensure sustaining product quality, preventive maintenance and updated calibration
  • Plan and manage internal, external and supplier audits
  • Interface with notified bodies and regulatory agencies for quality certifications
  • Conduct material review boards, CAPA and manage non-conforming materials
  • Support risk management, design validation and verification and design controls
  • Use analytical skills for root cause investigation and statistical sampling plans
  • Collaborate with R&D, manufacturing, clinical, regulatory and marketing groups

 

Qualifications:

 

  • Bachelor’s in Electrical, Mechanical or Biomedical Engineering
  • 10-15 years of professional experience, including 8 years in healthcare quality systems
  • In-depth knowledge of 21 CFR 820, ISO 13485, GMP and FDA requirements
  • Understanding of statistical techniques, risk management and process validation
  • Familiarity with electromechanical products, software and medical device development
  • Ability to multi-task and independently run cross-functional projects
  • Well-versed in Minitab (or equivalent), familiar with Solidworks, other analytical tools
  • Strong team leadership with ability to enforce quality policies and procedures
  • Independent, creative, collaborative with strong positive can-do attitude

 

Avation Culture:

 

We are seeking candidates who are:

 

  • Driven by the desire to bring innovative medical technologies to market
  • Passionate about applying themselves to improve the lives of patients
  • Intellectually curious, motivated by innovation and open to new ideas
  • Leaders who take individual ownership while placing high value on teams
  • Energetic and enjoy working in a fast-paced creative environment

 

Location:  Columbus, OH

Application: Qualified candidates should submit their application to JOBS@avation.Com

 

We are not working with recruiters at this time.

 

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  • Location
    Columbus, Ohio
  • Department
    Research & Development
  • Employment Type
    Full-Time
  • Minimum Experience
    Manager/Supervisor