Medical Device Quality Engineer

7 days ago


Dundee, Dundee City, United Kingdom Redshore Full time

**Job Summary**

Redshore is seeking a highly skilled Quality Systems Engineer to join its team in Dundee. As a Quality Systems Engineer, you will be responsible for the management, development, implementation, and continual improvement of an efficient and effective Quality Management System (QMS).

**Key Responsibilities:**

  • Plan and conduct internal quality audits (EN ISO 13485:2016) in accordance with the audit schedule and company procedures and work instructions, ensuring all applicable regulatory requirements are met.
  • Ensure follow-up activities are conducted, including verification of actions taken and reporting of verification results.
  • Identify, record, and investigate nonconformities/potential nonconformities in accordance with corrective and preventive action procedures.
  • Identify and implement process improvements in conjunction with line managers/process owners to ensure processes required for the QMS meet the requirements of relevant ISO standards and applicable regulatory requirements.

**Requirements:**

  • Experience working within a medical environment with exposure to ISO 13485.
  • Strong systems experience and knowledge of regulatory requirements.
  • Good communication and interpersonal skills.

**What We Offer:**

  • A competitive salary range of £45,000-£52,000.
  • A comprehensive benefits package, including pension, life assurance, medical cover, and excellent holidays.
  • Opportunities for training and development.

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