Quality Manager

Job Posting : Quality Manager

Position Title : Quality Manager

Location : Dayton OH

Employment Type : Full-Time

Summary of Position

We are seeking an experienced and detail-oriented Quality Manager to oversee the production of medical devices, from receipt of orders to shipment and documentation of finished goods. This role supports the development of internal systems and procedures to meet ISO and FDA / GMP requirements and is responsible for all monitoring and measurement devices.

As the Quality Manager, you will play a pivotal role in ensuring customer requirements are met while driving continuous improvement in processes and compliance.

Key Responsibilities

• Team Leadership : Build, manage, and sustain a team of technical quality associates involved in product development and in-process quality.
• Training & Development : Create and deliver training programs to instruct the workforce on quality and process tools.
• System Implementation : Support the development and maintenance of quality systems that meet ISO and FDA standards, including ISO certification.
• Continuous Improvement : Drive waste reduction and support company objectives through data analysis and corrective actions.
• Quality Integration : Ensure quality objectives are embedded into manufacturing processes, driving early defect identification.
• Inspection Oversight : Supervise quality engineers and inspection processes using statistical sampling and precision instruments.
• Compliance : Verify adherence to production procedures and maintain accurate records per FDA and customer guidelines.
• Audits : Represent the company during customer and regulatory audits and participate in Internal Review Board activities.
• CAPA & Lean Initiatives : Lead corrective actions, six sigma projects, and lean manufacturing improvements.
• Budget Management : Provide budget inputs and track costs to align with strategic objectives.
• Customer Interaction : Collaborate directly with customers on dock-to-stock programs and quality performance metrics.
• Process Validation : Oversee validated processes and documentation required for customer approvals.
• Equipment Management : Manage the purchase, calibration, and control of monitoring and measurement devices.
• Project Leadership : Implement projects related to Process Flow, Quality Systems, and Statistical Process Controls.

Experience & Education

Skills & Qualifications