Job Description

 

 

PURPOSE OF THE POSITION 

 

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 RESPONSABILITIES
 
  • 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 QUALIFICATIOS

 

ESCOLARIDAD: B.S. in Engineering, Science, or equivalent

INGLES              Blingual – written and oral (English/ Spanish).

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