First Base Employment Limited

Job Objective:

To represent the Quality department, primarily in the injection moulding area, and other manufacturing areas. To Quality Lead CAPA and 8D investigations, and to drive and promote continuous improvement, working closely with the CI&T and Production departments. Work within and assist to maintain an ISO 13485 environment through internal auditing

Role:

  • Build effective cross functional relationships and contribute to achieving and maintaining, certification to IS0 13485 a Medical Device standard.
  • Build excellent relationships with internal customers to identify their requirements and deliver these within the organisation
  • Creation and maintenance of quality documentation to support all manufacturing activities
  • Support all aspects of Quality for injection moulded products within the organisation
  • Provide dedicated Quality Engineering support for allocated project / area in particular our injection moulding facility.
  • Support the implementation of new products and production technologies
  • Develop Quality metrics, drive implementation and report result to the Leadership team
  • Deliver all aspects of Quality Engineering activities in line with targets, KPIs and milestones
  • Support the team in Root Cause Analysis (RCA) using a practical problem-solving approach
  • Apply analytical skills and judgement to generate solutions to technical challenges

Person Specification:

  • Educated to Degree, HND, HNC, NVQ4/5 Level, in a relevant engineering discipline
  • Expert knowledge of Quality Engineering tools, including APQP, PFMEA, SPC, Process Capability, MSA, Root Cause Analysis, able to lead deep dive fault finding into all moulding/manufacturing processes.
  • Extensive Quality Engineering experience gained within an Automotive, Medical Device or Pharmaceutical manufacturing environment
  • Ability to coach and mentor colleagues through structured training sessions and workshops
  • Working knowledge of Microsoft Office packages including excel
  • Ability to work on own initiative
  • Attention to detail is a must.
  • Ability to work accurately and within strict deadlines
  • Excellent written and verbal communication skills
  • Excellent organisational, planning and administrative abilities
  • Professional attitude

Desirable:

  • 6 Sigma Green / Black Belt Qualification – Highly Desirable
  • Internal Auditor experience
  • Experience with injection moulding
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