Quality Assurance Manager

6 days ago

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

Advanced Medical Solutions is seeking a highly skilled and experienced Quality Assurance Manager to lead our site quality function in Plymouth. As a key member of our operations team, you will be responsible for ensuring the successful delivery of our Quality Strategy and compliance with regulatory requirements.

Key Responsibilities
  • Lead the site quality team in the development and implementation of quality systems, ensuring compliance with MDR and MDSAP regulations and Group procedures.
  • Drive the execution and implementation of quality strategies, ensuring effective delivery of new product development and maintenance of quality management system certification.
  • Manage the site quality budget and ensure adequate support for effective delivery of new product development.
  • Act as site management representative, establishing and managing quality improvement projects in accordance with company objectives.
  • Ensure the quality deliverables of NPD products are designed and developed in compliance with design control and validation requirements.
  • Responsible for decision making 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, with a proven track record of delivering quality results.
  • Proficient in knowledge of applicable Quality System Regulations and ISO quality requirements.
  • Knowledge of the Medical Device regulation and proficiency in QA, Manufacturing, Validation, Change Control, and Design Control processes.
  • Proficient in spreadsheets and word processor applications, with a strong understanding of statistical analysis and analytical methods.
  • Ability to independently plan, execute, and problem solve moderate to complex situations, exercising judgment within generally defined practices and policies.
  • Solid oral and written communication skills, with the ability to manage multiple projects and generate succinct reports.

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