Sr. Quality Manager
Avalign Technologies, Schaumburg, IL, United States
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%
What You Won’t Do:
Feel stuck – we offer great opportunities to advance and learn
Get bored – we make a high variety of products, so no day is the same
Feel like a number – we’re a close-knit bunch and always have each other’s backs
Who You Are:
A self‑starter who thrives in a fast‑paced environment
A quick learner who is always ready to gain depth of knowledge in manufacturing processes
A reliable individual who knows the importance of showing up when it counts
Someone who accepts assignments with an open, cooperative, positive and team‑oriented approach
Someone who is able to plan and execute plans across teams
An effective communicator, both written and verbal
What You’ll Enjoy:
Competitive compensation and benefits package
Comprehensive medical, dental, and vision insurance
Paid vacation and 10 observed paid holidays per year
Employer funded Basic Life and AD&D insurance
Employer funded STD and LTD insuranceGreat 401(k) with company match
Working for a thriving, performance‑based company that values promoting from within and career advancement
Temperature controlled environment
Community involvement investing and giving back to the community
Additional free resources such as travel assistance, EAP, etc.
Avalign conducts a comprehensive background, drug testing, highest level of education completion verification, and reference checks.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, national origin, gender identity, sexual orientation, age, marital status, veteran status, or disability status. We are an employer that participates in E‑Verify and will provide the federal government with your Form I‑9 information to confirm that you are authorized to work in the U.S.
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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%
What You Won’t Do:
Feel stuck – we offer great opportunities to advance and learn
Get bored – we make a high variety of products, so no day is the same
Feel like a number – we’re a close-knit bunch and always have each other’s backs
Who You Are:
A self‑starter who thrives in a fast‑paced environment
A quick learner who is always ready to gain depth of knowledge in manufacturing processes
A reliable individual who knows the importance of showing up when it counts
Someone who accepts assignments with an open, cooperative, positive and team‑oriented approach
Someone who is able to plan and execute plans across teams
An effective communicator, both written and verbal
What You’ll Enjoy:
Competitive compensation and benefits package
Comprehensive medical, dental, and vision insurance
Paid vacation and 10 observed paid holidays per year
Employer funded Basic Life and AD&D insurance
Employer funded STD and LTD insuranceGreat 401(k) with company match
Working for a thriving, performance‑based company that values promoting from within and career advancement
Temperature controlled environment
Community involvement investing and giving back to the community
Additional free resources such as travel assistance, EAP, etc.
Avalign conducts a comprehensive background, drug testing, highest level of education completion verification, and reference checks.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, national origin, gender identity, sexual orientation, age, marital status, veteran status, or disability status. We are an employer that participates in E‑Verify and will provide the federal government with your Form I‑9 information to confirm that you are authorized to work in the U.S.
#J-18808-Ljbffr