Quality Engineer II

Quality Engineer II

Location:

Monroe, US, 28110

Employment Type:

Permanent

• 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.
• Present 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

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/Solid Works
• 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

We provide equal opportunities for everyone and see diversity as our strength. Therefore, we welcome all applicants – regardless of identifying characteristics such as gender, age, background, social status, veteran status, sexual orientation, religion, or mental and physical abilities. We have additionally set the goal of empowering women and increasing female leader representation. We foster an inclusive work environment and encourage all individuals to apply.

Job