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Senior Associate – Quality Assurance

alcon · Mulgrave

Senior 🇬🇧 English
ISO 9001 ISO 13485 FDA QSR 21CFR820

Job description

About the role

Alcon is seeking a Senior Associate in Quality Assurance to support the development and delivery of high‑quality eye‑care products. You will work closely with cross‑functional teams to ensure product designs, assemblies, and processes meet stringent regulatory and customer standards.

Key responsibilities

  • Develop deep expertise on Cylite product designs, assemblies, and documented processes.
  • Assist the Quality Manager in creating Quality Control plans and procedures.
  • Collaborate with Quality, NPI, Production, and Engineering to define quality benchmarks, acceptance criteria, and regulatory compliance.
  • Perform in‑process QC inspections and tests according to established plans.
  • Investigate root causes of non‑conforming products, drive corrective actions, and support continuous‑improvement initiatives.
  • Lead or participate in process capability monitoring (SPC) and CAPA activities.
  • Prepare documentation for internal and external audits and generate quality data reports.

Required profile

  • Bachelor’s degree in Engineering or Physical Sciences.
  • Minimum 4 years of experience in a quality role within manufacturing, preferably medical devices, pharma, optics, electronics, or automotive.
  • Strong attention to detail, self‑driven, and able to prioritize tasks to meet project milestones.
  • Excellent oral and written communication skills for cross‑functional collaboration.

Required skills

  • Knowledge of ISO 9001 quality management systems.
  • Knowledge of ISO 13485 medical device standards.
  • Familiarity with FDA QSR 21CFR820 requirements.
  • Experience with Statistical Process Control (SPC) tools.
  • Proficiency in Corrective and Preventive Action (CAPA) processes.

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Source : ats:workday

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Published 1 month ago

Expires 1 week from now

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alcon

Mulgrave