CAPA Administrator-contract position

Job Summary – Assure product conformance to established requirements and standards through appropriate audit, inspection, and test activities.  Administration of the Corrective and Preventative Action System (CAPA).

 

General Functions ?
Quality Engineering

? Coordinate quality planning inspection method development, and defect prevention/corrective action processes for new and existing products.
? Serve as a team member on Trauma Development projects and conduct quality system audits and assessment of internal manufacturing cells and supplier manufacturing sites as necessary.
? Identify and recommend production and process issues, perform employee certifications, support various operation/manufacturing groups and suppliers in resolving and/or preventing quality issues.
? Assist the Manager, Quality Assurance in the development and implementation of quality strategies and objectives.

CAPA administration

? Participate in the implementation of the CAPA software solutions program.
? Administer CAPA.  Administrative duties that include but are not limited to the monitoring of information relative to problem statements, root cause analysis, corrections, corrective and preventative actions.
? Provide communication to responsible individuals for timely completion and documentation of activities.
? Serve as a resident expert in CAPA regulatory/compliance.
? Monitor the effectivity of the CAPA system.
? Coordinate all needed training for users of the CAPA system.
? Serve as the Chairman of the Warsaw Executive CAPA committee.
? Present CAPA information during Management Reviews.
? Maintain and revise applicable procedures as necessary.

This is not an exhaustive list of duties or functions and may not necessarily comprise all of the "essential functions" for purposes of the ADA

Expected Areas of Competence (i.e. KSAs) ?
? Familiarity with good Manufacturing Practices and QSR/ISO regulations.
? Familiarity with all aspects of modern quality control/assurance techniques such as, inspection methods, statistical sampling plans, corrective/preventative action plans, first article layout, gauging concepts, FMEA, validation, and SPC
? Expert knowledge an ability in blueprint reading and Geometric Dimensioning and Tolerancing.
? Good understanding of machine and manufacturing processes and capabilities
? Detail orientated
? Ability to exercise good judgment in determining the reasonableness of actions.
? Ability to work with minimum supervision.
? Innovative with the ability to make sound suggestions for improvement.
? Possess effective presentation and writing skills.

 

Education Requirements ?
Requires a Bachelor?s degree in engineering or an alternative Bachelor?s degree in the physical sciences.
2-5 years experience in a Quality Engineering field.

 

Licenses/Certifications ? Certification as a Quality Engineer (e.g. CQE)

Skill Requirements ?  Ability to use basic computer systems including software solutions for CAPA, Microsoft Office etc

Travel Requirements ? Less than 5%