Our client is a multi-national medical device manufacturer whose mission is to improve the quality of life through the design, development and manufacture of high quality, affordable medical products, for the benefit of patients and health professionals. We are assisting them to recruit for an experienced Quality Systems Engineer to join their team in Westmeath.
- Implementing the CAPA Process with cross functional teams through thorough Root Cause Investigation, timely CAPA Planning and Implementation by selecting appropriate problem-solving techniques and making robust and consistent engineering and quality assurance recommendations.
- Conduct Internal Audits, Corporate Audits and Third-Party Audits as required.
- Quality System support for Third Party Audits both announced and unannounced as part of the audit response team to include front room and back-room activities.
- Analysing Quality Systems data to provide input into KPI’s, Management Review Quality Metrics Review and Post Market Surveillance Data.
- Responsible user for quality management system related IT. Provide Quality Support to Software Validation for QMS.
- Independently & Analytically assess and provide guidance on quality system records.
- Bachelor’s degree in Engineering, Science or related subject.
- Lead Auditor or Internal Auditor certification an advantage.
- A minimum 5 years’ experience in Quality and/or Compliance within the Medical Device Industry, Pharmaceutical and /or other highly regulated Industry is required.
- Excellent organizational and project management skills.
- Demonstrated ability to work effectively with cross- functional teams for problem-solving, product and process improvement is required.