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Senior Quality Engineer

Senior Quality Engineer role in Dublin, Ireland, onsite position.
LetsGetChecked
On-Site
Ireland
USD 56,654 - 62,320
EUR 50,000 - 55,000
Job Description
LetsGetChecked is seeking a Senior Quality Engineer to join their team in Dublin. This role is crucial for ensuring that the company's products and processes adhere to relevant regulations and standards. The Senior Quality Engineer will be responsible for evaluating current products and processes, reviewing and approving change controls, validating manufacturing equipment, participating in audits, leading risk management activities, and mentoring the Quality team. This is an onsite role.

Responsibilities include:
  • Evaluating products and processes for regulatory compliance.
  • Reviewing and approving change controls.
  • Validating manufacturing equipment and processes.
  • Participating in internal and external audits.
  • Leading risk management activities.
  • Collaborating with cross-functional teams.
  • Mentoring Quality team personnel.
  • Analyzing potential issues and making decisions on non-conforming products.
  • Contributing to CAPA investigations.
  • Staying updated on regulatory changes.

Requirements:
  • Minimum 5 years of relevant experience in an engineering or quality role.
  • Good working knowledge of ISO 13485, 21 CFR Part 820, MDR 2017/745, IVDR 2017/746, ISO 14971.
  • Proficient in using SAP S/4 HANA, particularly the Quality Management (QM) module.
  • Experience with internal and external audits.
  • Experience in reviewing technical documentation.
  • Experience with new product introduction.
  • Knowledge of root cause analysis.
  • Hands-on using Statistics, Lean and Six Sigma methodologies.
  • Ability to work independently in a fast-paced environment.
  • Project and people management skills.
  • Excellent analytical, troubleshooting, and communication skills.

LetsGetChecked offers:
  • Health insurance and an Employee Assistance Programme
  • Pension matching contribution
  • Annual Compensation Reviews
  • Flexible Annual Leave Policy
  • Free monthly LetsGetChecked tests
  • A referral bonus programme
  • Internal Opportunities and Careers Clinics
  • Bike to work scheme
  • Maternity, Paternity, Parental and Wedding leave
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LetsGetChecked

LetsGetChecked is a global healthcare company providing at-home health testing, virtual care, genetic sequencing, and medication delivery. Their end-to-end model encompasses manufacturing, logistics, lab analysis, physician support, and prescription fulfillment. Co-headquartered in Dublin and Atlanta, LetsGetChecked empowers individuals to proactively manage their health.

All Jobs at LetsGetChecked (16)