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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.
• 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 principles
• Performs tasks accurately and with great attention to detail
• 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.
• 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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