We are looking for a Quality Engineer to become a member of the team!
Conducts root cause analysis and implementation of corrective action for process/product-related concerns.
Responsible for continual improvement activities to enhance the quality system, such as 5S, Kaizen lean methods, etc.
Interfaces with Engineering and Operations to ensure transfer to production of new products are in accordance with approved data.
Deals with Customers, Sales, and Engineering on APQP activities for new programs.
Works with Engineering to coordinate and prepare sample submission packages; updates and maintains PPAPs, FMEAs, Process Flow diagrams, and Process Control Plans
Works with Engineering and Operations to solve in-house quality concerns, reviews of nonconforming products, recommends disposition.
Conducts investigations on non-conformance and recommends corrective action to prevent reoccurrence.
Supports the Quality Inspectors to ensure that products and processes comply with the relevant requirements of the quality management system.
Conducts audits, including closing out audit findings, creating audits finding reports, and determines proper corrective and preventive actions within ISO 9001, TS16949, and ISO 13485 quality systems.
Analyzes failures and implements corrective and preventive action to respond to customer complaints.
Creates and maintains company quality documentation, such as quality procedures, work instructions, etc.
Preparation of various quality reports
This list is not all-inclusive and other duties may be assigned as needed.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions; CQE or CQA preferred
Six Sigma Green Belt certification preferred; Sound knowledge of GD&T, FMEA, DOE, GR&R activities; Sound knowledge of APQP/PPAP processes; Must be able to read and interpret engineering drawings, schematics, and specifications; Sound knowledge of ISO 9001, TS16949, and/or ISO 13485 quality systems
Education and/or Experience:
Bachelor’s Degree in a technical/engineering field preferred; Minimum 5 years experience in Quality Assurance in a manufacturing environment (rubber components and/or medical manufacturing preferred); Must have a strong working knowledge of Statistical Process Control methods using intermediate and advanced statistics.
Intermediate MS Office – must be able to create a variety of charts and reports to support quality activities; Experience with MiniTab desired