Quality Engineer, Advanced Woundcare Specialist

1 month 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, driving process improvements through the use of chemistry or chemical engineering knowledge, SPC, Process Capability, and Quality tools.
  • Collaborate with R&D, Manufacturing teams, and suppliers to ensure compliance throughout new product development and technical projects.
  • Use technical and GXP knowledge to influence and assure Quality and Compliance in Design, developing plans for New Product Development/Post Launch/lifecycle management activities.
  • Support Cost of Quality and Automation Projects to aid with AWC, while aiding the Advanced Operation team.
  • Provide support as subject expert in Statistical Sampling, Quality Sampling, CTQ Characterisation, Risk Management activities, and assists Design Control/Transfer.
Requirements:
  • Degree or equivalent in science, engineering, or related discipline.
  • Strong knowledge and experience of CAPA and NC, as well as ISO 13485, 21 CFR Part 820, and 21 CFR Part 803.
  • Experience in implementing/review of pFMEA, and Six Sigma green belt qualified or demonstrated ability in the use of quality engineering tools and techniques.
  • Competent auditor with experience in hosting or acting as SME during external regulatory audits.
What We Offer:

At ConvaTec, we're committed to providing a supportive and inclusive work environment that allows our employees to grow and develop their careers. We offer a competitive salary and benefits package, as well as opportunities for professional development and advancement.

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