Quality Assurance Engineer

Job Description

Quality Assurance Engineer

Our client is a visionary medical imaging company who are developing exciting medical devices. 

Job Purpose and Primary Objective

The role is essential to ensuring products are designed, developed and manufactured to a high quality and to supporting compliance to regulatory requirements. Requires close and proactive working with design/development engineering team and purchasing and materials control personnel.

Roles and Responsibilities

  • Carrying out in coming goods inspections in line with quality control processes - generation, review and approval of records and ensuring compliance to the requirements of ISO 13485:2016 and MDD / MRD. If missing, QC processes shall be established.
  • Perform final QC Inspection and Installation activities.
  • Assist in the supplier management process, supplier selection, quality agreements, conduct supplier audits and measure supplier performance when required.
  • Track and record equipment calibration status and ensure equipment is re-calibrated when required.
  • Develop, generate, review and maintain documentation to support an effective and compliant Quality Management System, including: Quality Inspection Procedures and Control Plans; Material and Product Specifications; Process Flow Charts; Quality Systems and Process SOPs and Work Instructions; R&D Protocols & Reports; Product and Process FMEAs / Risk Assessments
  • Support company departments in maintaining the product technical files.
  • Creating and maintaining the device history records (DHR1s)
  • Rapid investigation of failure modes, establish root causes of product/process failures and establish resolution for non-conformities and customer feed-back & complaints.
  • Assure Corrective and Preventive Action plans are developed and executed in compliance with the CAPA process.
  • Assure engineering change principals are applied and change control process is followed in accordance with applied standards and regulations.
  • Conduct, report and track internal quality audits.
  • Develop and deliver Quality Systems training programs as required.
  • Measure analyse and report performance data for company processes. Support line manager in creating Management Review Agenda.
  • Support company departments with general quality and processes development and advice. Collaborate cross functionally to resolve Product Lifecycle Quality issues.
  • Assist the design teams and manufacturing in identifying and resolving product/process problems (these include product release and production issues). They will ensure issues are fully closed out including full risk mitigation and compliance.
  • Support the introduction of new products and processes into our contract manufacturer,
  • Assist with verification & validation tests.

Education & Qualifications Requirements:

  • 5+ years' experience within Quality Assurance / Quality Control
  • Previous experience in a QC / QA role minimum 5 years and have very good understanding of quality assurance activities.
  • Ideally you will have experience or an understanding of auditing against ISO 13485 and MDD/MDR.
  • Reliable, proactive and able to work to deadlines
  • Excellent attention to detail
  • Excellent people and communication skills
  • Sense of urgency - make things happen/get results and problem-solving skills
  • Good organisational skills
  • Good working knowledge of Office 365