Quality Engineer

Job Title

The major purpose of this position is to lead the on-going quality activities required to support commercialized medical devices for the company. This role provides quality engineering leadership by: Collaborating with R&D and manufacturing on product opportunities post-commercialization, monitoring and analyzing complaint data, leading root cause corrective actions and proactively supporting business strategies. These activities include but are not limited to: Support design changes, product enhancements, material changes, and process changes; investigation of product non-conformances; communication with customers, ensure compliance to quality system requirements; support the company's manufacturing facilities and supply base.

Roles and Responsibilities

Actively participates in and/or facilitate the development of deliverables required to qualify product design changes ensuring that customer requirements and specifications are met

Maintains the Risk Management files which includes Hazards Analysis, Design FMEA, Use FMEA & Process FMEA for assigned product families

Solves challenging technical problems, provides expertise in related specific field of knowledge and consults on complex issues and projects

Works within cross-functional teams to lead investigation of customer product complaints as needed

Utilizes Root Cause Analysis concepts to investigate issues and implement Corrective and Preventive Actions including effectiveness checks

Leads Global Post Market Surveillance analysis, trending, and reporting

Ensures timely closure of assigned active complaints (typically 3rd party supplied products) providing tracking and trending data, as needed

Partners with vendors to facilitate the completion of Supplier Corrective Actions and to build quality relationships

Develops, initiates, and implements new quality concepts, tools and strategies to improve business practices

Provides technical leadership in solving more challenging technical problems related to quality issues and technologies

Assists with the transfer of knowledge of technical skills and is viewed as a Subject Matter Expert

Conducts self in accordance with the expected company behaviors

Ensures that all elements of the corporate Human Resources Development and Diversity policy are fully supported as appropriate for the position

Required Qualifications

B.S. in Engineering, Science, or equivalent

Blingual – written and oral (English/ Spanish)

Minimum of 5 years of collective experience in product development, manufacturing and/or quality within a medical device environment