New job Quality Engineer - Presque Isle, Maine in Maine

SUMMARY OF DUTIES: Ensure conformity of Medical Devices and compliance with all customer requirements. quality management system standards and applicable statutory and regulatory requirements.

Design & Process validations (IQ,OQ,PQ).

ESSENTIAL DUTIES: Perform quality reviews of product specification documentation for compliance with stated requirements.
Applies statistical process control (SPC) methods for analyzing data to evaluate the current process and process changes.
Reviews all data obtained during all quality assurance activities to ensure consistency with company policies and procedures.
Develops new approaches to solve problems identified during quality assurance activities.
Keeps management team abreast of significant issues or developments identified during quality assurance activities and actions being taken to improve the situation.
Prepares and presents technical and program information to the management team.
Directs technical and administrative workers engaged in quality assurance activities.
Maintains a working knowledge of government and industry quality assurance codes and standards.
Plays an active role on quality management teams within the organization.
Designs and implements quality assurance training programs to key personnel in conjunction with managers.
Perform internal audits within the company's facilities.
Visit, confer and/or assist representatives of vendors to obtain information related to supply quality, capacity of vendor to meet orders, and vendor quality standards.
Confer with the applicable departments about quality assurance of new and/or existing products to ensure product quality. Confer with the applicable departments for manufactured products on the market to rectify problems.
Identify, create, implement and maintain quality assurance system documentation for the assurance of conformity to customer, quality management system standards, and applicable statutory and regulatory requirements.
Investigate customer complaints, perform root cause analysis, identify corrective action, and prepare reports for customer submission. Includes verbal, written and direct customer contact with regards to complaint resolution.
Investigate internal non-conformances, perform root cause analysis, identify corrective and preventative action, and prepare reports.
To discontinue further processing and delivery of non-conforming product until the discrepancy or non-conforming condition has been corrected.
To initiate actions to prevent the occurrence of product non-conformity.

EDUCATION LEVEL: Bachelor's degree (B. A.) in a technical field, preferably engineering or science and/or an Associat

EXPERIENCE: