Quality Control Supervisor 2 (MedTech)

TL;DR

Quality Control Supervisor 2 (MedTech): Supervising quality control sections and manufacturing product lines for immunodiagnostic and molecular diagnostic solutions with an accent on production scheduling, staff management, and regulatory compliance. Focus on leading process validations, managing Out of Specification investigations, and ensuring strict adherence to FDA and ISO standards.

Location: Onsite in Northbrook, Illinois, USA

Salary: $75,000 - $100,000

Company

Global leader in immunodiagnostic and molecular diagnostic solutions advancing science to improve patient outcomes worldwide.

What you will do

• Supervise quality control personnel and manage daily work schedules, priorities, and task delegation.
• Ensure attainment of production schedules for finished products, incoming materials, and stability samples.
• Investigate Out of Specifications (OOS), document non-conformances, and lead Material Review Board activities.
• Perform in-process quality control sampling and analytical testing within a high-complexity manufacturing environment.
• Execute equipment and process validations and participate in the integration of new products into manufacturing.
• Develop and implement approved departmental procedures, policies, and process improvements.

Requirements

• Location: Must be based in or able to work onsite in Northbrook, Illinois
• Associate's degree in Chemistry, Biological Sciences, or related field with 8+ years of experience, or Bachelor's degree with 5+ years of experience.
• 2+ years of relevant Quality Operations leadership experience in an FDA regulated or ISO certified organization.
• Knowledge of clean/HEPA filtered manufacturing environments and purified water systems.
• Proficiency in ISO 13485 and FDA Quality Systems.
• Experience with MRP systems such as Oracle or SAP and Product Life Cycle Management tools.

Culture & Benefits

• Comprehensive health benefits, retirement, and financial wellbeing programs.
• Time off programs and wellbeing support perks.
• Eligibility for an annual incentive program based on individual and organizational performance.
• Entrepreneurial environment focused on innovation, accountability, and continuous development.