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: None
O-ADP1548
