Quality Manager

Viant•Wheeling, IL

About The Position

We’re a company of agile, customer-oriented individuals with a shared commitment to integrity, servant leadership, and teamwork. Our associates take pride and ownership in their work, and innovate to provide the highest quality, life-enhancing medical technology in the world. Together, We’re in It for Life. The Quality Manager is a key member of the Plant Leadership team and serves as the site Quality leader and Management Representative, overseeing all aspects of the quality systems process in an FDA and ISO 13485 regulated medical device environment. This highly responsible role requires strong leadership, customer relations, and organizational skills, managing a team of 20+ associates (including 7 direct reports) at our three buildings.

Requirements

Bachelor’s degree in Engineering, Quality, or related field.
5+ years of experience in Quality Assurance and Regulatory Affairs within medical device manufacturing or any regulated industry (Automotive or Aerospace)
Strong knowledge of ISO 13485, FDA, and Corrective Action Plans processes.
Experience with internal/external audits and maintaining a robust Quality Management System.
Knowledge of CMM programming and inspection systems.
Ability to read and interpret blueprints and technical drawings.
Proficiency in MS365 applications (Word, Excel, PowerPoint).
Experience Oracle and IQS proficiency (Required).

Nice To Haves

Experience with Power BI (user level) (Preferred).
Experience and knowledge with statistical systems as Minitab for statistical analysis

Responsibilities

Support and uphold Viant Values: Customer Oriented, Integrity, Servant Leadership, Own It, Teamwork, and Be Agile.
Provide strategic leadership for all quality assurance and regulatory programs, ensuring continuous improvement and compliance with FDA, ISO 13485, and customer requirements.
Lead the design, implementation, and maintenance of systems for document control, training, corrective and preventive action, discrepancy handling, complaint handling, product release, and environmental monitoring.
Review and approve quality system documentation; develop and maintain procedures for QA and regulatory functions.
Collaborate with plant leadership and corporate quality to drive adherence to processes and achieve KPIs.
Manage quality engineering support and indirect inspection teams to improve efficiency and resolve root causes.
Interact with customers and suppliers on all quality matters, ensuring strong relationships and satisfaction.
Handle direct selection, training, and development of quality personnel; coach and mentor team members.
Oversee internal/external audits, CAPA programs, and implement corrective actions to improve product quality.
Communicate and act on revisions, validations, and quality-related requirements; ensure robust QMS and customer satisfaction.
Manage and communicate all quality-related information, including revisions, validations, audits, and customer requirements.
Interpret and implement corrective actions to address product quality issues as requested by customers.
Maintain a robust Quality Management System that meets all FDA, ISO 13485 and customer requirements.
Perform other duties as needed