Quality Manager

Company Info
Dynamix Group
OH, United States

Web Site: http://dynamix-group.com/

Company Profile


Quality Manager


Cleveland, OH 

Job ID:


Job Description:

Quality Manager

Cleveland, OH


  • Oversee and manage all department activities within the Quality Assurance Department.

  • Maintain knowledge of quality standards and regulations including proposed and final rules.

  • Lead external audits/inspections (preparation, execution, and responses).

  • Ensure that quality management system requirements are effectively established and maintained.

  • Enforce compliance with regulatory requirements through internal and external auditing and maintain evidentiary records by supporting procedure development, implementation, and reviews appropriate to the organization.

  • Collect, analyze, and trend quality data.

  • Ensure robust investigations and solutions are developed as part of the Quality Systems processes.

  • Act as Quality Approver for quality records and final release of product.

  • Manage customer complaint files to ensure global regulatory compliance including the review for possible adverse events and MDR.

  • Manage CAPA (corrective and preventive action) and focus on continuous improvement and customer satisfaction.

  • Evaluate, monitor, and audit vendors.

  • Review and approve supplier’s documentation and records (e.g., quality plans, process validations, etc.).

  • Ensure that team members are trained to the organization’s processes and necessary standards.

  • Ensure that audits of the quality system are performed in an efficient, timely and complete manner.

  • Report to top management on the performance of the quality management system and ensure the promotion of awareness of regulatory requirements throughout the organization.

  • Participate in design reviews for new products.


  • Bachelor Degree required, preferably in a technical discipline or possess a technical aptitude.  

  • 5+ years of quality management experience.

  • 1+ years of management or leadership of people or projects with the ability to work within cross-functional teams.

  • A working with medical devices (preferably class II and class III).

  • Strong knowledge of ISO13485, 21 CFR Part 820, EU MDR 2017/745, and MDSAP.

  • Detail oriented, hands-on manager.

  • Experience with new product development or engineering highly preferred.

  • Strength in data analysis, trending, and forecasting of numbers.

  • Ability and interest in “rolling up sleeves” to perform “hands-on” quality.

  • Flexibility and ability to self-start on new challenges, problem-solving with minimal supervision.

  • Ability to work efficiently on multiple tasks with deadlines in a small company where job duties/priorities may change.

  • Ability to work in a diverse team with members of varying education and experience levels.