Banner Default Image

Permanent

Senior Quality Systems Engineer

  • Location

    Wales

  • Salary

    Negotiable

  • Sector

    Engineering

  • Job Ref

    89381

  • Contact

    Luke Morgan

  • Published

    26 days ago

Overview

Senior Quality Systems Engineer

Are you an experienced Senior Quality Systems Engineer with a proven track record in the medical device industry looking to join a dynamic organisation?

Our client is a global leading company within the medical device industry who strives for excellence when it comes to their products, customer service, and sales. It's a great time to be joining such a business due to the global harmonisation of their systems creating a really dynamic environment with lots of opportunity to contribute to process and system changes.

The successful candidate will focus on all QMS related functions- install, maintenance & improvement, as well as audits (conducting internal and hosting external), CAPAs, non-conformances, deviations, complaints etc. On top of this, the candidate will be able to lead by example as a Senior and help improve the team where necessary by communicating clear targets and objectives along with positive/negative feedback.

Benefits:

  • Generous Pension Scheme
  • Free Life Assurance
  • Private Medical Insurance
  • 25 days Annual Leave (plus bank holidays)
  • Bonus Scheme
  • Hybrid Working

Experience:

  • Diploma level Science/Engineering/Quality orientated qualification
  • Lead Auditor qualification (ISO 9000 series based quality system essential, ISO13485 preferred)
  • Significant experience working in a QA/QS environment within the medical device or pharmaceutical industry.
  • Knowledge of ISO13485, Medical Device Directive MDD 93/42/EEC, Regulation (EU) 2017/745 and FDA QSR Part 820
  • Good analytical skills and experience of statistical techniques
  • Computer literate to include MS Word and Excel and MRP
  • GMP and audit qualifications
  • Supervisory experience.
  • Ability to work with minimal supervision and use initiative.
  • Good interpersonal skills and the ability to communicate well in English both written and orally.
  • Good record/documentation skills.
  • Works with integrity, customer focus, accountability and teamwork.

Austin Fraser is acting as an Employment Agency in relation to this vacancy.

Austin Fraser is committed to being an equal opportunities employer, and encourages applications from candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity status.

Due to the volume of applications received, we are unable to provide individual feedback to unsuccessful applicants.