Job Description:



This is a targeted role to support BDPI - PPA franchise in completing test method validations.



 Responsibilities:



Learn Product Line



Collaborate with New Product Development (NPD) team on test method development.



Write and/or execute test method validation protocols using all appropriate DHF and RMF records



Execute (or coordinate execution of) test method protocols



Write TMV reports.



Review and approve related documentation.



Oversee and assure documentation and procedures are followed, updated and maintained as required by internal Quality Policies and related FDA/GMP guidelines.



Qualifications:



Experience writing and executing test method validations in the medical device industry



Technical Degree such as a bachelor's degree in engineering or applied science from an accredited university.



Able to work on-site in Vernon Hills as necessary to interact with products and team members and run tests in lab.



Must demonstrate a working understanding of the pertinent Quality Systems Regulations.



Proven ability to develop solutions to a variety of problems of moderate scope and complexity, using policies and procedures for guidance.



Capable of using Microsoft programs and ability to learn other systems.



Working knowledge of statistical methods as well as statistical application software.



Effective verbal and written communication skills.



The ability to work in teams and independently with minimal supervision to obtain results as required.



Must be self-motivated/directed, organized, detail oriented and have ability to multi-task projects.



Professional certification is an advantage (i.e. CQA, CQE, SQE, CQM, Six Sigma, etc.).