Senior Manager of Quality Manufacturing - Plurogen
Core
Manage quality and regulatory compliance for medical device or drug combination product platforms, ensuring adherence to QSR, GMP, and ISO standards across the product lifecycle.
Role type
Senior Manager of Quality Manufacturing
Builds
compliant medical device and drug combination products
Domain
Medical Devices / Pharmaceuticals
Required skills
Regulatory compliance (QSR, GMP, ISO), risk management, data analysis, project coordination, policy interpretation, team management, hiring, performance reviews, budget management
Preferred skills
Supervisory/managerial experience, experience in Medical Device, Pharmaceutical, Food, Cosmetic, or Personal Products Industries
Technologies
Microsoft Excel (pivot tables, AVERAGE, merging cells)
Responsibilities
Ensure quality and regulatory compliance with applicable regulations; Act as a liaison with Divisions, Suppliers, Manufacturing, and Operations; Manage complaints and develop problem-solving approaches; Identify and manage continuous improvement projects; Assist in planning design, testing, inspection, and process validations; Resolve quality issues to customer satisfaction; Oversee professional employees or non-professional employees through Supervisors; Interpret and execute departmental policies; Hire staff, recommend pay increases, and conduct performance reviews
Seniority
Senior, hands-on IC with management responsibilities
