Quality Manager

4 weeks ago


Plymouth, Plymouth, United Kingdom Advanced Medical Solutions Full time
About the Role

Advanced Medical Solutions is seeking a highly experienced Quality Manager to lead our site quality function in Plymouth. As a key member of our operations team, you will be responsible for ensuring the quality management system is compliant with regulatory requirements and Group procedures.

Key Responsibilities
  • Lead the site quality team to ensure compliance with MDR and MDSAP regulations and Group procedures.
  • Drive the successful execution and implementation of quality strategies.
  • Ensure site quality team members are well-trained and motivated.
  • Prepare and manage budget for the site quality function.
  • Act as site management representative, where required.
  • Establish and manage quality improvement projects in accordance with company objectives.
  • Ensure adequate support for effective delivery of new product development.
  • Maintain quality management system certification.
  • Responsible for the continuous improvement of the quality management system.
Requirements
  • BSc or equivalent in a scientific discipline or equivalent experience in the medical device or pharmaceutical industries.
  • Leadership experience in previous roles.
  • Proficient in quality system regulations and ISO quality requirements.
  • Knowledge of the Medical Device regulation.
  • Proficient in QA, manufacturing, validation, change control, and design control processes.
  • Proficient in spreadsheets and word processor applications.
  • Proficient in concepts of statistics, sampling plans, and statistical analysis.
  • Ability to independently plan, execute, and/or problem solve moderate to complex situations.
  • Solid oral and written communication skills.
  • Ability to manage multiple projects.


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