Sr. Quality Manager

Avalign Technologies • Schaumburg, IL

1d • Onsite

About The Position

Avalign is seeking a Sr. Quality Manager at its facility in Schaumburg, IL. This role involves leading and directing regulatory (e.g., FDA and ISO), internal, and external (customer) audits to ensure compliance with applicable regulatory and corporate standards. Key responsibilities include developing and maintaining an audit schedule, performing internal audits, managing the CAPA system, and verifying corrective actions. The manager will also develop and analyze trending data for quality systems to identify areas for continuous improvement, maintain current knowledge of regulations, and function as a resource for Quality System matters. The position requires reporting on and adhering to quality Key Performance Indicators (KPIs), coordinating continuous improvement processes, and ensuring high levels of internal and external customer service. The Sr. Quality Manager will supervise quality assurance and control activities, develop and analyze statistical data, and apply expertise in project management and problem-solving to resolve technical and systemic issues. Additionally, the role involves interpreting scientific and technical data for reports, mentoring and developing employees, and driving broader quality system improvements across Avalign in collaboration with other Quality Leadership Team members.

Requirements

• Bachelor’s degree required
• 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 15%
• Proficient in GD&T
• Quality Inspection Experience
• ISO 13485 Quality Control Experience
• Precision Measurement & Hand Metrology
• Advanced Inspection & Gauge Measurement
• Quality Control Data Analysis

Nice To Haves

• Bachelor’s degree in an engineering or technical field preferred
• 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

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 251-500 employees