Benefits Include:

Professional Development/On the Job Training Health and Wellness Benefits Clean, Friendly, Safe work Environment Recognition and Rewards Program Tuition Re-imbursement Competitive Pay/Merit Increases 401k w/ Company Match Employee Assistance Program (EAP)

POSITION SUMMARY

The Quality Systems Engineer is primarily responsible for the following: Oversee effective implementation of the Quality Management System (QMS). Lead and undertake audits across all areas of the business. Provide training and champion the Quality Management System. Manage CAPA and Complaints systems and reporting performance.

ESSENTIAL FUNCTIONS

Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. Perform root cause analysis and resolve problems. Manage the CAPA and Customer Complaint Systems. Perform data analysis and trending and report such trends in management reviews. Oversee effective implementation of the Quality Management System, including any business accreditations. Maintain the Quality Management System and ensure contents are appropriate for business, in collaboration with the Quality Manager. Organize and manage the plant internal audit system and the corrective action reporting system. Conduct Quality Systems audits and assist in training/guidance to internal auditors. Assist/support Quality Manager during external Quality System audits. Provide training on Quality issues and awareness. Coordinate the review of Quality procedures associated with plant continuous improvement initiatives. Compile quality data and report on Key Performance Indicators (KPIs) to adhere to process and prevent occurrence of any non-conformity relating to product, process, or system. Employees must be able to relate to other people beyond receiving instructions. Can get along with co-workers or peers and respond appropriately to feedback from a supervisor in a professional manner.

OTHER RESPONSIBILITIES

Promote the use of customer preferred techniques for continuous improvement such as Six-Sigma, Poka-Yoke (Error Proofing), and Measurement System Analysis. Keep up with current and developing manufacturing and engineering trends that concern product quality. Support and lead process improvement activities. Understand the sensitivity of the data handled by systems under your control and take appropriate measures to protect it.

EDUCATION AND EXPERIENCE

EDUCATION:

Bachelor's degree in an engineering field, or relevant technical field (STEM) preferred, but not required.

EXPERIENCE

3 year(s) of progressive experience in manufacturing and/or quality in an FDA, and

ISO 13485

operating environment, demonstrating acumen, and understanding of QMS and Operations; equivalent combinations or education and experience accepted OR demonstrated ability to execute the Essential Functions for this position.

LICENSES, CERTIFICATIONS AND/ REGISTRATIONS

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Quality Systems Engineer - Injection Molding