Hybrid Quality Systems Manager

at Prentke Romich GmbH

• Job title: Quality Systems Manager
• Job type: Full Time
• Experience level: Junior
• Salary: $80,000 - $100,000 per year
• Degree requirement: Bachelor's Degree
• Tech skills: ERP
• Location requirements: Hybrid, Wooster, United States

About the role

• Quality Systems Manager responsible for maintaining quality management systems ensuring compliance with regulations. Collaborating across departments to drive continuous improvement initiatives.

Responsibilities

• Maintain an efficient, compliant quality management system (QMS) to ensure objectives are met and corrective actions are implemented as needed.
• Assign, monitor, and support corrective and preventive actions (CAPAs), observations (OBs), and opportunities for improvement (OFIs).
• Develop and deliver monthly CAPA, OFI, and OB reports for the Leadership Team and produce annual performance improvement reports.
• Collaborate with departments to develop, maintain, and ensure adherence to required processes and procedures.
• Facilitate and support assessments, audits, and inspections conducted by regulatory agencies and certifying bodies.
• Serve as the primary contact for QMS software, overseeing implementation, training, support, and ongoing improvements.
• Proactively manage organizational risk by implementing systems to prevent failures, reduce recall likelihood, and mitigate compliance risk.

Requirements

• Bachelor’s degree in a Quality or Compliance related field required.
• At least one year of professional experience in regulatory affairs or quality management systems related to medical devices required.
• Strong analytical and organizational skills with the ability to coordinate multiple activities and delegate effectively.
• Thorough knowledge of quality management systems, manufacturing planning, inventory control, and production processes.
• Working knowledge of ISO 13485, FDA, ACHC, and European Medical Device Regulation (EUMDR) requirements.
• Excellent written, verbal, and interpersonal communication skills.
• Self-motivated with the ability to work independently under minimal supervision.
• Team oriented mindset with the ability to collaborate across all organizational levels.
• Flexibility and adaptability in a fast paced, changing environment.
• Proficiency in Windows and Microsoft Office (Word, Excel, PowerPoint) and experience with document control and ERP systems.

Benefits

• Mission Driven Work: Support a culture of quality and compliance that helps improve lives.
• Leadership Impact: Play a key role in shaping and maintaining company wide quality systems.
• Cross Functional Collaboration: Work closely with teams across the organization to drive continuous improvement.
• Continuous Improvement: Lead initiatives that strengthen processes, mitigate risk, and enhance performance.