Quality Assurance Leader

1 week ago


Athlone, County Westmeath, Ireland beBeeQuality Full time €90,000 - €110,000
Senior Quality Assurance Professional

We are seeking a highly skilled Senior Quality Assurance Professional to join our team. In this role, you will be responsible for ensuring the quality of our products and services.

Key Responsibilities:
  • Representing the Quality Assurance function in site management meetings as required.
  • Acting as a delegate for the Quality Lead.
  • Leading and implementing significant process improvements, projects, and cost-saving initiatives using data and quality tools to drive quality decisions.
  • Initiating, reviewing, approving, and providing guidance on change controls.
  • Performing, analyzing, and interpreting statistical data using a detailed understanding of statistical tools and methods.
  • Giving guidance to Quality Engineering in the development of sampling plans.
  • Leading investigations and providing technical guidance to peers in relation to CAPAs, NC/NCMRs, and SCARs to address compliance issues and providing guidance to suppliers and engineering.
  • Ensuring compliance is maintained for product manufacturing, packaging, and labeling.
  • Performing and leading internal and supplier audits.
  • Facilitating and participating in external regulatory body audits, e.g., ISO and FDA.
  • Implementing key performance indicators within the Quality Assurance area to align with site and global quality objectives.
Requirements:
  • Degree in Engineering or Science-related field.
  • Five (5) years' experience working in a regulated environment, specifically medical device, FDA, or ISO 13485 registered work environments is preferred.
  • Strong computer skills (MS Excel, PowerPoint, Word).
  • Strong knowledge of statistical tools and techniques.
  • Strong knowledge of FMEA's (Failure Mode and Effects Analysis) and root cause analysis tools.
  • Strong knowledge of problem-solving techniques.
  • Ability to effectively communicate highly technical information, both verbally and in writing, to both non-technical and technical associates.
Work Environment:
  • Hybrid Eligible (Job Duties allow for some remote work but require travel to Athlone at least 3 days per week)
  • Travel: Flexible and available to support business needs as required.
Benefits:
  • Solventum offers many programs to help you live your best life – both physically and financially.
Diversity & Inclusion:
  • We are an equal opportunity employer and value diversity at our company.

Please note that all job postings from Solventum regarding job opportunities will be from an email with a domain of @solventum.com.



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