Senior CAPA Engineer Team Lead

Posting Date 4 weeks ago(9/2/2020 10:50 AM)
Requisition ID
2020-7706
Job Location(s)
West Lafayette IN United States
Travel
Less than 10%
Position Type
Full Time
Company
Cook Biotech Inc.
Category
Engineering

Overview

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.

Responsibilities

 

·        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.

Knowledge

·        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.

Decision-Making

·        Gather the facts and communicate them to key stakeholders.

·        Propose solutions and decisions.

·        Collaborate with others to make key decisions.

Collaboration

·        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.

Communication

·        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.

Other

·        Conduct other corporate duties when required.

 

Qualifications

 

·        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

 

 

 

Options

Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed