Quality Engineer II

Your challenge

Job Responsibilities:
•    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

Authority:
•    Approval of fixture designs for inspection equipment
•    Concession disposition of nonconforming product 

Your Profile

•    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

Physical Requirements:
•    Must be able to work overtime as needed
•    Must be able to sit, stand and walk for up to 8 hours
•    Must be able to lift up to 70 lbs