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Employer Fastnet The Talent Group
Job Title Senior Continuous Improvement Engineer

Senior Continuous Improvement Engineer
The successful candidate will analyze data of non-conforming events, supply quality issues, to determine the root cause of issues, lead teams to design and execute proactive solutions to eliminate and troubleshoot quality related issues.

Key Responsibilities:

  • Leads and manages investigations to identify root causes, establishes corrective actions and executes prevention plans in products and/or processes (both internal and external)
  • Approves and defends corrective actions for deviations, provides formal structured approach to assist in determining root cause for nonconforming events and evaluate CAPAs for lifecycle effectiveness
  • Reviews Validation Protocols, Deviations, Investigations and other forms of Quality documentation as assigned
  • Assure timely completion of assigned CAPA items
  • Proficient in process, product, and data review within respective field of operation in accordance with job responsibility and function, able to troubleshoot process, material and technique-related issues
  • Monitor the site specific indicators for CAPAs/Deviations/Complaints as appropriate and escalate potential outliers or negative trends to the appropriate areas as needed.
  • Works with Quality Organization to collect Voice of Customers and understand non-conforming events
  • Works with the Supplier Management Organization to mine, analyze data and drive root cause analysis and corrective actions that will help eliminate supplier related technical quality issues
  • Analyzes data/metrics using sound statistical practices. Develops and implements solutions based on statistical analysis
  • Researches and writes special investigations for trends. Reacts quickly to trends and issues detected by quality intelligence data and effectively addresses them.
  • Ability to travel domestically and internationally as needed

  • Minimum of 5 years of Quality Engineering experience or Manufacturing Process Engineering experience within the medical device industry.
  • Bachelor's degree from an accredited institution in an Engineering, Mathematics, Physical Science or Technology discipline.
  • Root cause analysis; data-driven decision making; and strong risk analysis skills.
  • Must have a good understanding of medical device quality regulations and GMP; strong computer skills; excellent written/verbal/communications; strong interpersonal skills; and must be able to perform in a fast-paced, team environment.
  • Coursework in Quality Engineering, statistics, project management
  • Lean Six Sigma preferred
  • Ability to travel up to 40% of time

Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.

Fastnet - The Talent Group
'Not Just Placers.........Partners'

The Life Science Specialists

This job originally appeared on
Location Cork
Date Added 276 days ago
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