Job Description
We are seeking a Quality Engineer to support the closure of Quality Records with Logistics and Distribution Subject Matter Experts. The successful candidate will possess a broad and increasing knowledge of Quality to complete moderately complex assignments. Key responsibilities include identifying problems and possible solutions, ensuring compliance with applicable standards, and providing quality input to current processes. The Quality Engineer will also be responsible for writing and maintaining Logistics teams SOPs, providing training, and developing relevant metrics and trending.
About Abbott
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines.
Responsibilities:
- Possesses and applies a broad and increasing knowledge of Quality to the completion of moderately complex assignments.
- Identifies problems and possible solutions and takes appropriate action to resolve.
- Ensures compliance with applicable standards for the Corrective and Preventative Action (CAPA) process and the Quality Incident process.
- Writes and maintains Logistics teams SOPs, provides training, and develops relevant metrics and trending.
- Assists or performs gap assessments and implements Corporate Policy requirements under the Quality system of the Distribution Centres.
- Identifies and mitigates any supply Chain quality risks and provides quality input to current processes.
- Supports the Logistics Distribution team within the Abbott Document Control system to write new Quality System documents or maintain existing documents, process document change requests, and coordinate the approval of SOPs, Work Instructions, and Forms.
- Provides Logistics supplier audit metrics that may be used in support of Management Review.
- Documents and executes validation protocols needed to ensure Quality System and Regulatory compliance at the Distribution Centres or other sites as needed.
- Supports environmental validations in the Distributions Centres as needed.
- Performs and supports internal, Abbott site, and supplier audits as required.
Requirements:
- Bachelor's degree in Engineering, Chemistry, Biotechnology, Life Science, or a related technical field or equivalent experience and education.
- 3+ years' experience in a medical device company in a quality or regulatory function.
- Demonstrated experience with applicable regulatory standards and requirements.
- Ability to apply statistical tools in complaint trend analysis and utilize data analysis methodologies.
- Strong communication skills (written and verbal across cultures).
- Highly numerate with an aptitude for analysis.