Quality Assurance Manager

7 days ago

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

We are seeking a highly skilled Quality Assurance Manager to join our team at Advanced Medical Solutions. As a key member of our site operations management team, you will be responsible for ensuring the quality management system is compliant with regulatory requirements and company procedures.

Key Responsibilities
  • Lead the site quality team in the development and improvement of the quality management system.
  • Ensure compliance with MDR and MDSAP regulations and company procedures.
  • Drive the successful execution and implementation of quality strategies.
  • Manage and motivate the site quality team to ensure they are well-trained and equipped to perform their duties.
  • Prepare and manage budgets for the site quality function.
  • Act as site management representative as required.
  • Establish and manage quality improvement projects in accordance with company objectives.
  • Ensure adequate support for new product development and that quality deliverables are met.
  • Maintain quality management system certification.
  • Responsible for the continuous improvement of the quality management system.
  • Make decisions related to quality issues, root cause analysis, and remedial action to avoid product recalls.
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.
  • Ability to exercise judgment within generally defined practices and policies.
  • Solid oral and written communication skills.
  • Ability to manage multiple projects.
  • Good written and oral communication skills.
  • Computer literate with knowledge of Word, PowerPoint, and Excel.

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