Quality Assurance Specialist

1 month ago


Leeds, Leeds, United Kingdom Surgical Innovations Ltd Full time
About Us

Surgical Innovations Ltd is a leading UK manufacturer of medical devices, with over 30 years of experience in designing, developing, and manufacturing high-quality instruments for minimally invasive surgery.

Job Overview

We are seeking a Production Quality Engineer to support the introduction of new and improve existing Quality and Manufacturing processes. The successful candidate will possess previous experience in regulated manufacturing with exposure to both NPI and validation/verification activities.

Key Responsibilities
  • Carries out change, validation, and risk assessment activity in support of manufacturing processes, equipment, and software.
  • Works with a cross-functional team to prepare DOE, IQ, OQ, and PQ & CSV protocols in line with the site validation and project improvement plans.
  • Completes process and quality data analysis to support validation and improvement activity and KPI trending using Minitab and Excel software.
  • Supports Quality with investigation of complaints, NC, and CAPA, carrying out root-cause analysis, identifying, and implementing permanent solutions.
  • Assists with the implementation of corrective actions following customer complaints (CAPA) and both internal and external NCRs.
  • Supports Quality Control on quality issues, programs, systems, Gauge R&R, etc.
  • Supports new product development NPI to facilitate on-time and budget delivery of projects and transfer into manufacturing.
  • Runs detailed mechanical test programs and produces fully auditable technical reports.
Requirements
  • Experience of Process and Product Improvement and Validation within regulated environments, ideally Medical Device or automotive, oil & gas, aerospace, pharmaceutical industries.
  • Strong experience of measurement/inspection activities.
  • Professional attitude and flexible approach to working.
  • Efficient, with great attention to detail, and commercial awareness of project deadlines.
What We Offer

This position offers a competitive salary of £35-£38,000, accompanied by a range of benefits including flexi-time, pension, life assurance, income protection, health cash plan, high street discount scheme, and bonus scheme.



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