Quality Manager

3 weeks ago

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

Advanced Medical Solutions (AMS) is a world-leading independent developer and manufacturer of innovative tissue-healing technology. Our mission is to deliver quality outcomes for patients and value for payers.

Job Details

We are seeking a highly skilled Quality Manager to lead our site quality function and ensure the successful delivery of our Quality Strategy. The successful candidate will be responsible for managing the quality management system, including continuous improvements, CAPA management, document management, quality planning, internal and external audits, validation, risk management, and continuous Quality Management Review.

Key Responsibilities
  • Lead the site quality team to ensure compliance with cGMP, MDSAP, and MDR regulations.
  • Develop and implement quality strategies to drive business growth and improvement.
  • Ensure the quality management system is effective and efficient, with a focus on continuous improvement.
  • Manage the quality budget and ensure effective resource allocation.
  • Act as site Management representative, as required.
  • Establish and manage quality improvement projects to drive business objectives.
  • Ensure adequate support for new product development, with a focus on quality deliverables.
  • Maintain quality management system certification.
  • Responsible for decision-making related to quality issues, root cause analysis, and remedial action.
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.
  • Ability to independently plan, execute, and/or problem solve moderate to complex situations.
  • Solid oral and written communication skills.
  • Ability to manage multiple projects.
What We're Looking For

We are looking for a highly skilled and experienced Quality Manager who can lead our site quality function and drive business growth and improvement. If you have a passion for quality and a proven track record of delivering results, we want to hear from you.

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