Academic Quality Specialist

4 days ago


Plymouth, Plymouth, United Kingdom Adecco Full time
Quality Manager Job Description

Job Title: Quality Manager

Location: Plymouth

A leading medical device company is seeking a dynamic and experienced Quality Manager to drive continuous improvements and ensure the delivery of the Quality Strategy.

Key Responsibilities:

  1. Provide leadership to the site quality function, including quality systems, quality engineering, and QC analytical and Microbiology.
  2. Manage the successful delivery of the Quality Strategy to achieve corporate goals and objectives.
  3. Ensure compliance with MDSAP regulations and the Medical Device regulation (MDR).
  4. Prepare and manage the budget for the site quality function.
  5. Ensure effective delivery of new product development by overseeing quality deliverables and compliance with design control and validation requirements.
  6. Make decisions related to quality issues, conduct root cause analysis, and implement corrective actions to avoid product recalls.
  7. Review and approve supplier and customer quality agreements to meet compliance and operational requirements.

Requirements:

  1. Bachelor's degree or equivalent in a scientific discipline or 4+ years of experience in the medical device or pharmaceutical industries.
  2. Proficient knowledge of applicable Quality System Regulations and ISO quality requirements.
  3. Familiarity with the Medical Device regulation.
  4. Strong knowledge of QA, Manufacturing, Validation, Change Control, and Design Control processes.
  5. Solid understanding of statistical methods, sampling plans, and statistical analysis.
  6. Experience with analytical methods, equipment, process, software, cleaning, and/or facility/utility validations.


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