Senior CAPA Engineer Team Lead

Posting Date 4 weeks ago(9/2/2020 10:50 AM)
Requisition ID
Job Location(s)
West Lafayette IN United States
Less than 10%
Position Type
Full Time
Cook Biotech Inc.


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

  • Must be able to perform the essential functions of the job, with or without reasonable accommodations.
  • Limited exposure to hazardous chemicals and/or biohazards
  • Must be able to perform the essential functions of the job, with or without reasonable accommodations.
  • Limited exposure to hazardous chemicals and/or biohazards





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