QUALITY ASSURANCE
Candidate will be responsible for assisting the QA Manager with quality planning inspection, method development, and defect prevention/corrective action processes for new and existing products as well as 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.
This individual will identify and recommend production and process issues, perform employee certifications, support various operation/manufacturing groups and suppliers in resolving and/or preventing quality issues.
In addition, a large part of the candidate's responsibility will involve CAPA administration.
This individual will be expected to participate in the implementation of the CAPA software solutions program and Administer CAPA.
This will involve administrative duties including the monitoring of information relative to problem statements, root cause analysis, corrections, corrective and preventative actions.
Candidate will provide communication to responsible individuals for timely completion and documentation of activities and serve as resident expert in CAPA regulatory/compliance.
Further, this candidate will monitor the effectiveness of the CAPA system, and coordinate all needed training for users of the CAPA system.
Education/Experience: Bachelor's degree in engineering or an alternative Bachelor's degree in the physical sciences.
2-5 years experience in a Quality Engineering field.
Familiarity with good Manufacturing Practices and QSR/ISO regulations and good understanding 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 and a good understanding of machine and manufacturing processes and capabilities.
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