Sr. Quality Manager

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