Avalign is currently seeking a Sr. 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 15%

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 accept 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 insurance
Tuition reimbursement
Great 401(k) with company match
Generous employee referral bonus program
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.

You should be proficient in:

GD&T
Quality Inspection Experience
ISO 13485
Quality Control Experience
Precision Measurement & Hand Metrology
Advanced Inspection & Gauge Measurement
Quality Control Data Analysis

Machines & technologies you'll use:

Optical Comparator
Coordinate Measuring Machine (CMM)
Measurement Gauges
Calipers and Micrometers