Quality Systems Engineer

ZipRecruiter; Manchester; On-site; GBP 35,000 - 55,000; Full time

Job summary

A leading company in the medical device sector is seeking a Quality Systems Engineer to enhance their Quality Management System. This role involves managing documentation, supporting audits, and ensuring compliance with quality metrics. Ideal candidates will have a background in engineering or science, with experience in regulated environments.

Qualifications

• 2+ years’ experience in QMS or document-centric environment.
• Experience with medical device documentation preferred.
• Prior auditing experience is a plus.

Responsibilities

• Administer the electronic Quality Management System.
• Review and approve Quality System Records.
• Support Corrective and Preventive Action program.

Skills

Experience in QMS

Documentation in regulated field

Strong communication skills

Ability to learn custom software

Multitasking

Education

Degree in Engineering or Science

3+ years experience without a degree

Job description

Job Description

DEKA R&D has an immediate opening for a Quality Systems Engineer to work in the Quality Department within a dynamic Medical Device Research and Development environment. The position reports to the Quality System Manager. This is a high visibility role with a significant direct impact on the Quality Management System.

How you will make an impact:

• Administer the (electronic) Quality Management System
• Review and approve Quality System Records, including Complaint records
• Process changes for QMS Procedures (SOPs):
  • Make red-line changes
  • Create new master documents, archive, and distribute via electronic system
  • Track training for QMS documents within the Change Order process
  • Track open impacts to completion
• Act as Lead Training Coordinator and CAPA Coordinator
• Administer the site calibration program
• Support the site Corrective and Preventive Action program
• File records manually and electronically
• Support QMS collection and trending of quality data
• Use statistical tools to monitor and report on quality metrics
• Manage QMS databases for action items and implementation
• Support vendor qualification and management
• Support external and internal audits
• Aid in the development of training programs
• Provide training to company personnel as required
• Generate quizzes or other methods to ensure competency following training

Skills needed to be successful:

• 2+ years’ experience in QMS or a document-centric environment with a degree in Engineering or Science, or 3+ years’ experience without a degree
• Experience with documentation in a regulated field (medical device experience is preferable)
• Prior auditing experience is a plus
• Strong written and verbal communication skills
• Ability to:
  • Learn custom software programs
  • Multitask and see tasks through to completion
  • Manage multiple data sources and develop reports

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