Search Jobs

Quality Engineer (QA Operations)

Reading Metro Area, PA

Posted: 01/04/2019 Job Type: Scientific Job Number: JN -012019-23329
Description:
The Quality Engineer is responsible for working with the Quality and Manufacturing teams to support activities during the overall product life cycle of the assigned production area(s). The QE will support improvement projects, quality issue resolution, Non-conformances/CAPAs, process control, product transfers and validations. In some cases, the QE will be required to lead small to medium size projects.

MAJOR ACCOUNTABILITIES:
Provide Quality Engineering support and guidance to assigned production area(s) and review/approve product, process, and/or document non-conformances.
Supports product lifecycle (transfer through obsolescence) through data collection and analysis, implementation and revision of product conformance standards, continuous process improvement, reduction of reject levels and assigned projects and change control tasks, etc.
Ensure there are adequate product and process controls in place for identified critical or major quality attributes/process parameters within assigned production area(s). Complete gap analysis against local, global, and industry standards, as needed, and support development/execution of actions to close gaps under minimal guidance.
Investigate and/or provide input on non-conformance events and Corrective Actions and Preventive Actions (CAPA) while providing guidance and approval. Will track and trend non-conformance and CAPA data with guidance using various statistical and problem-solving tools.
Work with Manufacturing, Engineering, and other Quality functions to create a quality presence on the production floor to support the production process. Provide support for quality measurement and inspection systems and quality indicating measurement methods and standards.
Evaluate production processes and systems for conformance to local, global and industry standards/requirements.
Support and promote improvement activities for production area(s).
Uses various statistical and problem-solving tools as part of analysis of data, issues, non-conformances or improvement opportunities.
Manage product holds and quarantine when necessary.
Skills: Required:
Experience in a regulated industry (i.e. Medical Device, Pharmaceuticals, Food manufacturing or similar)

Preferred:

5+ years experience in regulated industry for Medical Device, Pharmaceuticals or equivalent.
5+ years of experience/involvement in manufacturing environment related to Quality Systems (CAPA, etc), process controls, auditing, and/or continuous improvement initiatives.
Experience in a regulated industry (i.e. Medical Device, Pharmaceuticals, Food manufacturing or similar)
Understanding of cGMP and ISO regulations.
Experience in project management with project management certification preferred.
Understanding of validation principles, risk analysis, statistics and/or process capability.
Understanding of LEAN and six sigma principles with Green Belt certification preferred.

Education:
Bachelor s Degree in Engineering or Science related field or equivalent years of directly related experience
Apply Online

Send an email reminder to:

Share This Job:

Related Jobs:

Login to save this search and get notified of similar positions.