Quality Manager

Avalign Technologies•Schaumburg, IL

2d•Onsite

About The Position

Avalign is currently seeking a Quality Manager at our facility located in Schaumburg, IL. What You Will Do: Lead and direct regulatory (e.g. FDA and ISO), internal and external (customer) audits within the company to ensure compliance to applicable regulatory and corporate standards / requirements are met. This includes developing and maintaining an audit schedule, performing internal audits, scheduling personnel to assist with audits, maintaining a list of qualified internal auditors, writing and issuing audit reports, and verifying corrective actions Manage a successful CAPA system, including initiation, support of the root cause investigation, closure, and verification of effectiveness Develop and analyze trending data for quality systems to determine areas for continuous improvement Maintain current knowledge base of regulations, corporate policies, and standards to ensure compliance. Functions as a resource person for matters related to the Quality System Report and adhere to quality Key Performance Indicators (KPIs) Lead the coordination of continuous improvement processes for the Quality System Ensure a high level of internal and external customer service. Provides an excellent customer experience Supervise workers engaged in various quality assurance and quality control activities to ensure high productivity and technical integrity Develop and analyze statistical data and product specifications to determine standards and to establish quality and reliability expectancy of products Expertise in project management and problem-solving skills, including the ability to identify, investigate and resolve technical and/or systemic issues Lead and interpret scientific and technical data and translate that into test reports, validation reports, or CAPA Mentor, coach, train, and develop employees Drive broader quality system improvements across Avalign in collaboration with other Quality Leadership Team members Complete other duties as assigned What You Will Need: Bachelor’s degree required, in an engineering or technical field preferred 3+ years experience in a Quality Assurance or Regulatory compliance role in the medical device or related industry Prior experience in a Quality Manager or similar leadership role preferred Experience in ISO 13485 and FDA 21 CFR part 820 requirements Ability to travel up to 25%

Requirements

Bachelor’s degree required, in an engineering or technical field preferred
3+ years experience in a Quality Assurance or Regulatory compliance role in the medical device or related industry
Experience in ISO 13485 and FDA 21 CFR part 820 requirements
Ability to travel up to 25%

Nice To Haves

Prior experience in a Quality Manager or similar leadership role preferred

Responsibilities

Lead and direct regulatory (e.g. FDA and ISO), internal and external (customer) audits within the company to ensure compliance to applicable regulatory and corporate standards / requirements are met. This includes developing and maintaining an audit schedule, performing internal audits, scheduling personnel to assist with audits, maintaining a list of qualified internal auditors, writing and issuing audit reports, and verifying corrective actions
Manage a successful CAPA system, including initiation, support of the root cause investigation, closure, and verification of effectiveness
Develop and analyze trending data for quality systems to determine areas for continuous improvement
Maintain current knowledge base of regulations, corporate policies, and standards to ensure compliance. Functions as a resource person for matters related to the Quality System
Report and adhere to quality Key Performance Indicators (KPIs)
Lead the coordination of continuous improvement processes for the Quality System
Ensure a high level of internal and external customer service.
Provides an excellent customer experience
Supervise workers engaged in various quality assurance and quality control activities to ensure high productivity and technical integrity
Develop and analyze statistical data and product specifications to determine standards and to establish quality and reliability expectancy of products
Expertise in project management and problem-solving skills, including the ability to identify, investigate and resolve technical and/or systemic issues
Lead and interpret scientific and technical data and translate that into test reports, validation reports, or CAPA
Mentor, coach, train, and develop employees
Drive broader quality system improvements across Avalign in collaboration with other Quality Leadership Team members
Complete other duties as assigned