This person is responsible for tracking and reporting progress on CAPA activities as well as working to complete (and help teammates complete) CAPA-related work in a timely manner.
· Complete and help teammates complete CAPA activities including non-conformance investigations, containment and corrections, root cause investigation, implementation planning, implementation activities, and verification of effectiveness.
· Determine CAPA completion timelines and communicate resource needs to CBI leadership.
· Ensure that required CAPA documentation is timely and accurate.
· Demonstrate effective CAPA completion skills with particular attention to writing skills, logical thinking, and effective collaboration.
· Ensure that quality system documents are modified and/or created as required.
· Coordinate prototype creation, testing, data collection, and investigation as required.
· Remain current and apply the understanding of FDA-ISO 13485 and quality system requirements in carrying out duties.
· Use and demonstrate competence with root cause analysis methodologies (e.g. 5 whys, fishbone analysis).
· Use and demonstrate competence with continuous improvement tools (e.g. 5S, value stream mapping, theory of constraints, kaizen).
· Maintain training on and constantly work to develop/improve process for CAPA documentation and execution.
· Seek new skills/knowledge relevant to CBI.
· Gather the facts and communicate them to key stakeholders.
· Propose solutions and decisions.
· Collaborate with others to make key decisions.
· Cultivate and listen carefully to assessments and ideas from throughout CBI.
· Routinely provide follow-up to those individuals and groups who provide ideas and assessments.
· Facilitate multi-department collaboration.
· Provide effective training on changes and new processes necessitated by CAPA.
· Understand and demonstrate effective writing skills appropriate for the medical device industry.
· Understand and demonstrate best practices for presenting information.
· Communicate resource needs related to CAPA.
· Assist in gathering and tracking key metrics related to CAPA completion.
· Communicate key metrics to management.
· Conduct other corporate duties when required.
· BS in engineering or related field, or equivalent experience
· Able to set goals for self and work to achieve milestones
· Able to work effectively on multiple projects simultaneously
· Able to understand basic statistics
· Able to operate statistical software such as JMP
· Able to solicit and listen to ideas from others throughout CBI
· Able to effectively communicate ideas to others
· Good record keeping and documentation skills
· Interest in working directly in a manufacturing environment
· Willing to work with material derived from animal tissues
· Sufficient background to generally understand medical and biotechnology terminology