Our client a Global Leader here in Galway are seeking applications from a suitably qualified and experienced Senior Quality Engineer. This is a permanent role.
The person will act as the EU Logistics and Distribution Subject Matter Expert (SME) for quality systems and/or subsystems and/or division processes. The successful person will be the team’s Process Owner for quality system processes. The Senior Quality Engineer will be responsible for ensuring compliance and continuous improvements for business processes relating to the Quality Management System.
- Possesses and applies a broad and increasing knowledge of Quality to the completion of moderately complex assignments.
- Applies problem-solving skills in order to deal creatively with complex situations, work that typically requires processing and interpreting, and more complex, less clearly-defined issues. Identifies problems and possible solutions and takes appropriate action to resolve them. Demonstrates skill in data analysis techniques by resolving missing/ incomplete information.
- In regard to the Corrective and Preventative Action (CAPA) process, the Quality Engineer will assist the team to ensure compliance with applicable standards. Write and maintain EU Logistics and Distribution SOPs, provide training and develop and generate relevant metrics and trending.
- The Quality Incident process also ensures compliance with applicable standards. Write and maintain the Logistics teams SOPs, provide training, and develop and generate relevant metrics and trends.
- For any Logistics Internal and External Audits will be responsible to lead or Assist audit support activities., plus assisting the team on any validations, and other studies for technical content, statistical rationale, risk, and clarity.
- Perform gap assessment and Implement Corporate Policy requirements under the Quality system of the Distribution Centres. Perform risk assessment for critical processes of the Distribution Centres.
- Identify and mitigate any supply Chain quality risks plus provide quality input to current processes and facilitate Quality Improvement initiatives.
- In addition, is involved with the Logistics Distribution team within the Company Document Control system to support the writing of new Quality System documents or maintenance of existing documents, processing document change requests, and coordinating the approval of SOPs, Work Instructions and Forms.
- Provide Logistics supplier audit metrics that may be used in support of Management Review.
- Develop and maintain data analytic tools to be used by the EU Distribution and Logistics. Expected to source complex data, program, with the coding of data, apply statistics to analyse specific data sets, use Business Intelligence (BI) and related tools to prepare and communicate data, collaboration with business to understand data needs
- Document and execute validation protocols needed to ensure Quality System and Regulatory compliance at the Distribution Centres or other sites as needed.
- Support the environmental validations in the Distributions Centres as needed.
- Perform and support internal, site and supplier audits as required.
- All duties to be completed in compliance with established business policies.
- Bachelor's degree in Engineering, Chemistry, Biotechnology, Life Science or related technical field or equivalent experience and education.
- 5+ years experience in a medical device company in quality or regulatory function
- Demonstrated experience in Data Analytics and Quality Statistics Analysis
- Demonstrated experience with applicable regulatory standards and requirements
- Must be proficient in Excel / SQL, at least one data visualization tool (Tableau, PowerBI, Qlikview)
- Ability to apply statistical tools in complaint trend analysis and utilize data analysis methodologies
- To facilitate the interaction with sites in different time zones, occasional out-of-hours working is required.
- Excellent communication skills (written & verbal across cultures)
- Highly numerate with an aptitude for analysis.
- Ability to lead meetings (by phone, video conference, and face to face) to drive results and build relationships.
For more information or a confidential discussion about this role please contact Michelle Mc Inerney.
091 706 717