Description
The Quality Engineer develops, practices, and promotes quality principles throughout the organization to achieve defined customer quality requirements and required regulatory compliance. In addition, this individual provides leadership and guidance to the organization to maintain compliance with QSR and ISO certification.This role is responsible for independently identifying, proposing solutions and implementing improvements to the quality and effectiveness of products and processes.
The position will oversee that the quality system requirements are effectively established and effectively maintained in accordance with 21 CFR Part 820 and ISO13485 (and other regulations as applicable) and for providing data regarding the performance of the quality system that will be presented to management with executive responsibility for review.
This role utilizes extensive internal and external partnering skills and must be knowledgeable with other cross-functional disciplines and processes such as R&D, Regulatory, Clinical and Manufacturing.
This role is expected to meet aggressive timelines, consistently achieving results through disciplined execution.
The ideal candidate has initiative and self-starters who seize the opportunity. They will drive growth and act as change agents within the organization. They will demonstrate strong communication skills and are able to influence at multiple levels.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
Continuous Improvement Engineering Activities:
- *CAPA Support
- Review and enter CAPA-related information into database in a timely manner
- Review CAPA plans for appropriate corrective actions and provide feedback to CAPA owners
- Assess and improve consistency, quality and timeliness of divisional CAPA execution through implementing and maintaining effective CAPA monitoring systems and review mechanisms
- Assist with root cause analysis
- Provide QMS metrics, trend analysis and reports to identify key process improvements for CAPA
- Facilitate meetings to address CAPA plans and implementation questions
- Support external/internal audits as necessary
- Maintain CAPA system and records
- *Post Market Surveillance
- Responsible for leading the Post Market Surveillance (PMS) program in accordance with international requirements, including US Food and Drug Administration (FDA) and European Medical Device Directive (MDD).
- Ensure complete information is provided from various inputs, such as customer surveys, customer complaints, international registries, governmental databases, literature, clinical trials, in-house testing, failure analysis, and adverse event reports.
- Oversee PMSR review teams in recommending actions that are proportionate to the risks associated with use of the company's devices.