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Your challenge
Responsibility:
•   Develop, maintain and monitor quality processes to ensure compliance to ISO and FDA regulations.
•   Quality representation for the development of new products and processes including evaluation of technical drawings, test methodologies, and validation to ensure compliance
•   Lead non-conformance investigations along with other departments to identify root cause and assure nonconforming products dispositioned properly.Â
•   Presents findings of trend review or nonconformances to team and/or management staff
•   Author technical reports regarding nonconformance and complaint investigations as well as effectiveness reports for completed CAPA
•   Completion of risk assessment such as pFMEA to identify risks to product for determining the concession release of material through the Material Review Board
•   Assist in determining quality improvements by using relevant statistical method to testing methodologies and/or manufacturing processes and leading improvement projects for safety, quality, and productivity based on findings
•   Represent Quality in change control process, validation, and continuous improvement activities for the Production and Quality Control departments as assigned
•   Analysis of Quality trends and reporting on them for management review as well as escalation of identified trends
•   Create, review and approve fixture designs and prototypes
•   Monitor the effectiveness of employee training required in the inspection processes
•   Author SOPs, test procedures, validation protocols and reports
•   Author engineering studies using scientific principlesÂ
•   Performs tasks accurately and with great attention to detailÂ
•   Other duties as assigned
Your Profile
Job Requirements:
•   Bachelor’s degree in engineering field or related field
•   2-5 years of experience in high volume regulated manufacturing industry in engineering field.Â
•   Working experience of Six Sigma, lean and Quality Management Tools
•   A broad knowledge of theory and principles of statistics and statistical process control
•   Experience with Access Database, Excel and complaint handling software.
•   Basic knowledge of medical device regulation, industry, and international standards.
•   Strong computer skills including QA applications, word processing, spreadsheets and databases
•   Ability to recognize and define problems, collect data, and develop conclusions
•   Ability to read and understand technical drawings and documents
•   Working experience on CAD/SolidWorks
•   Ability to work independently and take initiative
•   Excellent communication, analytical, trouble-shooting and interpersonal skills
•   A team player as well as the ability to work independently
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