Quality Engineer Advanced Woundcare

3 weeks ago

Deeside, Flintshire, United Kingdom ConvaTec Full time
Quality Engineer Advanced Woundcare

At ConvaTec, we're committed to delivering innovative medical solutions that improve the lives of millions. As a Quality Engineer Advanced Woundcare, you'll play a critical role in ensuring the quality and safety of our products.

Key Responsibilities:
  • Support Quality initiatives and Advanced Operations Quality focus for AWC & other Quality and process improvements through the use of chemistry or chemical engineering knowledge, SPC, Process Capability, and Quality tools.
  • Drive and support key quality and engineering activities such as pFMEA, process and product audits, Engineering and capability studies support, Quality control plan, documentation creation and review and the enforcement of Good Manufacturing Practice (GMP) standards.
  • Provide key supports to validation activities, generation and review of process risk assessment (, pFMEA), and development or implementation of in-process controls, tests, checks, and inspection to support process and continuous improvement initiatives.
  • Collaborate with R&D, Manufacturing teams and suppliers where appropriate, working on New product development and technical projects, ensuring compliance throughout.
  • Support Cost of Quality and Automation Projects to aid with AWC while aiding the Advanced Operation team.
  • Act as product stewards for process FMEA and provides input on process validation to ensure manufacturing routes are capable of producing product to specifications.
  • Support Complaint investigations through Root Cause Analysis and effective Corrective or Preventive Actions (CAPA). Leads or actively supports Product Change Control.
  • Perform internal and supplier audits as required. Uses auditing as a proactive tool for improvement as well as compliance and challenges existing practice where appropriate.
  • Execute elements of quality management of suppliers (onboarding, evaluation, SCARs) to support new or existing products.
  • Collates and shares information/data through reports and follows up on identified improvement opportunities. Actively participates and/or drives Quality System improvements as required.
Requirements:
  • Degree or equivalent in science, engineering, or related discipline
  • Strong knowledge and experience of CAPA and NC.
  • Knowledge and experience of Trackwise, PowerPoint and SAP. Preferably MINITAB.
  • Strong Interpersonal skills while experience in Cross functional deployment of projects.
  • Six Sigma green belt qualified and / or demonstrated ability in the use of quality engineering tools and techniques (quality core tools) and data interpretation.
  • A practical working knowledge of implementation of change control, and of all aspects of the process and computer systems validation lifecycle (preferred)
  • Demonstrated ability to lead multiple projects and motivate cross functional teams whilst ensuring that deadlines are met.
  • Competent auditor. Experience in hosting or acting as SME during external regulatory audits.
  • Experience in implementing/review of pFMEA.
Travel Requirements:

Position may involve travel up to 20% of the time, mostly within Europe but overseas travel is expected. Most trips will include overnight travel

Language:

Speaking: Yes English*
Writing/Reading: Yes English*

Working Conditions:

Working on site.

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