Supply Chain Quality Engineer
Quality Engineer – Supply Chain
My client is a highly desirable Medical Device design and manufacturing company in Galway, and is commutable from parts of Clare and Mayo. There’s a new vacancy for a Supply Chain Quality Engineer to join and contribute in a company developing new products and technologies to better the lives of their patients all over the world! In this role, you will act as the EU Logistics and Distribution Subject Matter Expert for quality systems and processes. As the successful Supply Chain Quality Engineer, you will be the team’s Process Owner for quality system processes. In this role you will be responsible for ensuring compliance and continuous improvements for business processes relating to the Quality Management System.
About the role:
- 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, more complex, less clearly-defined issues. Identifies problems and possible solutions and takes appropriate action to resolve. Demonstrates skill in data analysis techniques by resolving missing/ incomplete information.
- In regard to Corrective and Preventative Action (CAPA) process the Quality Engineer will assist the team to ensure compliance to applicable standards. Write and maintain EU Logistics and Distribution SOPs, provide training, develop and generate relevant metrics and trending.
- For the Quality Incident process also ensure compliance to applicable standards. Write and maintain the Logistics teams SOPs, provide training, develop and generate relevant metrics and trending.
- For any Logistics Internal and External Audits will be responsible to lead or Assist audit support activities., plus assist 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.
- Involved with the Logistics Distribution team within the Abbott Document Control system 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 which 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 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, Abbott site and supplier audits as required.
Attributes of the successful candidates:
- Ability to apply statistical tools in complaint trend analysis and utilize data analysis methodologies
- To facilitate the interaction with sites on different time zones, occasional out of hours working 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
- Degree in Engineering or other Scientific/Technical subject.
- 5+ years’ experience in a medical device company in a quality or regulatory function.
- Experience in Data Analytics and Quality Statistics Analysis
- Experience with applicable regulatory standards and requirements
- Ability to travel 20% of the time
- Must be proficient in Excel / SQL, at least one data visualization tools such asTableau, PowerBI or Qlikview.
For further information on this Supply Chain Quality Engineer role in Galway, please contact Marchon Monroe on 0860449473 / email@example.com
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