Quality Engineer II

Greiner•Monroe, NC

11d

About The Position

This role is responsible for developing, maintaining, and monitoring quality processes to ensure compliance with ISO and FDA regulations. The Quality Engineer II will serve as a quality representative for new product and process development, evaluating technical drawings, test methodologies, and validation to ensure compliance. They will lead non-conformance investigations with other departments to identify root causes and ensure proper disposition of nonconforming products. The position involves presenting findings of trend reviews or nonconformances to teams and management, and authoring technical reports related to investigations and CAPA effectiveness. A key responsibility includes completing risk assessments, such as pFMEA, to identify product risks and determine material release through the Material Review Board. The role also involves assisting in quality improvements by applying statistical methods to testing and manufacturing processes, and leading improvement projects for safety, quality, and productivity. The Quality Engineer II will represent Quality in change control, validation, and continuous improvement activities for Production and Quality Control departments. They will analyze and report on quality trends for management review and escalate identified trends. Additionally, the role includes creating, reviewing, and approving fixture designs and prototypes, monitoring the effectiveness of training for inspection processes, and authoring SOPs, test procedures, validation protocols, and reports. Engineering studies will be performed using scientific principles. The role requires accuracy and attention to detail, along with performing other assigned duties.

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

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