- 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.
- Regarding 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.
- In addition is involved with the Logistics Distribution team within the company’s 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, company 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.
- 4+ years’ experience in a medical device company in a quality or regulatory function
- Demonstrated experience in Data Analytics and Quality Statistics Analysis
- Demonstrated 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 tool (Tableau, PowerBI, Qlikview)
- 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.
Or call Megan Warr on 091507515 for a confidential conversation