Associate Quality Engineer

Position Summary

Growth, Culture, People and Careers: this is the Teleflex Advantage.

The Associate Quality Engineer will be expected to provide support to Quality, interact with customers and provide support for Engineering, Quality Systems, Projects and Process engineering. Specializations may include but are not limited to: document control; material, process controls and project support; CAPA / NC’s and internal audits
•    Work collaboratively with cross functional teams to track data, identify improvement projects and implementation to improve Key Performance Indicators. 
•    Schedule and participate in activities to support and maintain compliance with applicable regulatory and Quality Management System requirements. 
•    Support the maintenance and development of the corrective and preventative action (CAPA) system and internal non-conformance system to support the overall facility quality management system.  
•    Work collaboratively with cross functional teams on project functions related to quality
•    Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and   resolving quality issues.
 

Principal Responsibilities

•    This position requires creativity and foresight to work with operations and product development teams to ensure compliance to the Quality System, Process Control, Supplier Management, Corporate and other appropriate procedures for a variety of medical devices from inbound through outbound deliveries.  
•    Maintain company compliance with Quality System Regulations and ISO 13485 standards. Experience with FDA and ISO inspections and registration is a plus.
•    Actively participates in Internal audits, CAPA System, Document/Change Control, and other activities as needed.
•    Provide customer-related quality and regulatory inquiries’ support.
•    Compiles and writes training material and conducts training sessions on QMS & Quality assurance activities.
•    Lead implementation of continuous improvement projects 
•    Lead and provide Project Management support as needed.
•    Develops and initiates standard methods for inspection, testing, and evaluation, utilizing knowledge in related engineering fields.
•    All other duties as assigned.
•    Minimal travel may be required.
 

Education / Experience Requirements

To be considered for this role, please ensure the minimum requirements are evident on your resume.

•    Bachelor's degree in engineering or equivalent specialized experience with emphasis in Quality. 
•    1-3 years' experience within medical device / FDA regulated industry preferred.
•    Knowledge of Quality Systems Requirements (ISO 13485, CFR 820 & LATAM)
•    Project Management experience, preferred.
•    Experience with SAP applications (desirable)
•    Manufacturing or distribution experience preferred. 
•    Quality certification a plus (e.g. CQE, CRE, CQM, Six Sigma, etc.).
•    Bilingual (Spanish), preferred.
•    Relevant Experience working within Medical Device, Pharmaceutical, or other FDA-regulated Industry is an advantage.

Specialized Skills / Other Requirements

•    Strong communication skills, both oral and written with the ability to prioritize and meet deadlines for multiple projects. 
•    Experience with SAP applications is a plus.
•    Ability to work well in a fast-paced environment under pressure and maintain positive, enthusiastic attitude.
•    Eagerness to learn and expand responsibilities.
•    Ability to work effectively in a team environment and build strong working relationships.
•    Experience with systematic project management and problem-solving methodologies is preferred. 
•    Statistical analysis techniques with excellent verbal, written, and presentation skills.
 

Lead
•    Has a Sense of Purpose & Inspires others.
•    Has a desire & ability to “step up”.
•    Takes accountability.
•    Demonstrates critical judgement. 

Engage
•    Communicates with Impact.
•    Builds and sustains relationships. 
•    Plans and organizes. 
•    Is present & available. 

Develop
•    Develops Leaders.
•    Builds High Performance people & teams.
•    Invest in personal growth. 
•    Develops Organization capability.

Improve 
•    Creates value for the customer. 
•    Demonstrates Continuous Improvement via results. 
•    Creates a culture of inclusion & involvement.
•    Makes the tough calls when organizations are not performing. 

Demonstrates Functional Mastery
•    Adept at relationship building across functions and geography to effectively work with and leverage centers of excellence. 
•    Excellent computer skills (MS Word, Excel, and PowerPoint). 
•    Detail oriented and strong data driven analytical approach to quality processes.
 

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