Quality Engineer, Jobs, Scotland, Edinburgh/Midlothian, 5150

Quality Engineer - Edinburgh/Midlothian

Technology - IT- Testing
Ref: 5150 Date Posted: Monday 11 Dec 2017
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Quality Engineer

The Compliance Manager role primarily leads on Quality Assurance activities of the business processes. The role will report into the Head of Regulated Product and be a full time permanent position. Working with the team to ensure compliance of design and development activities as well as all other business areas addressed by the QMS. Key objectives for the role will include internal audits, working with the team to establish process validations, and support verification and validation activities.

Key Duties and Responsibilities

Within your role, your key duties and responsibilities include but are not limited to;

  • Schedule and conduct internal audits, and supplier evaluation
  • Liaise and support external and regulatory audits
  • Ensure that processes needed for the Quality Management System (QMS) are established and maintained
  • Work with team to ensure compliance
  • Report on the performance of the QMS; participate in quality management reviews
  • Investigate Complaints arising from customer Service desk
  • Participate in project reviews to ensure appropriate design controls are being met

Job Description

  • Promote awareness of quality and regulatory requirements
  • Support validation activities
  • To always work in accordance with company standards and regulatory guidelines
  • To actively meet individual, team and company aims and objectives.
  • To display company core values at all times.
  • To behave in a positive and professional manner.
  • To demonstrate clear and concise written and verbal communication skills.
  • To be highly self-motivated and organised.
  • To demonstrate excellent customer care skills.
  • To provide suggestions that will contribute to the development of the Company.
  • To work as part of the team and help foster good working relationships.
  • To actively keep updated with the company’s products and services.
  • To keep up to date with relevant industry developments.
  • To adhere to the Company Health and Safety policy
  • To report any unsafe conditions, equipment or practices immediately to the appropriate manager.
  • To develop yourself where appropriate by attending courses, meetings, training events, workshops and seminars, in order to not only develop yourself but also the company.
  • To follow all company policies and procedures.
  • To conduct any other duties as requested by your Manager

Qualifications and Training

  • Internal auditor ISO 13485
  • 5+ years’ experience preferable
  • Physical sciences to degree level desirable

Knowledge and Experience

  • Working with medical devices / IVD through development
  • Complaints handling and CAPA process
  • Process validation
  • Ability to work unsupervised
  • Able to apply compliance knowledge to software development lifecycle
  • Competent with software tools for reporting, and use of cloud based systems
  • Communicate effectively with team, peers and customers
  • Keen to learn, and use transferable skills
  • Methodical, and detailed approach
  • Willingness to take part in hands-on support

If you can tick some of the boxes below, then I would love to hear from you.