Quality Engineer II, Distribution

Position Summary

The Quality Engineer will be expected to provide support to Quality and Operations, interact with customers and provide support for Engineering, Quality Systems, Projects and Process engineering. Specializations may include but are not limited to:

•    Nonconformance and CAPA coordination and processing; 
•    Customer complaint investigations;
•    Process & product validations;
•    Customer Notification of Change evaluations;
•    Internal & external auditing responsibilities and support; 
•    Quality improvement projects; and 
•    Maintain compliance with applicable Teleflex Global & local Procedures and Policies

Principal Responsibilities

•    Nonconformance (NC) and CAPA processing – lead quality activities with respect to Conductor Material Review Board coordination; inspection methods, NC containment/correction/closure and CAPAs; and drive improvement through analysis of trend data. 
•    Customer Complaint Investigations – Primary investigator and facilitator for Conductor complaint investigation, confirmation and corrective actions. Act as primary customer contact on complaint communications. Drive improvement based on trends.
•    Process Validations – guide and review protocol development, validation implementation and report review an acceptance;
•    Quality & Cost Improvement Projects – lead and participate on key short term projects on product or process improvements;
•    Maintain company compliance with Quality System Regulations and ISO 13485 standards. Experience with FDA and ISO inspections and registration is a plus. 
•    Documentation Control – perform Customer Product Specification reviews. Compiles and writes training material and conducts training sessions on QMS & Quality assurance activities. 
•    Manage and lead implementation of continuous improvement projects  
•    Manage and lead and provide Project Management support as needed. 
•    Develops and initiates standard methods for inspection, testing, and evaluation, utilizing knowledge in related engineering fields. 
•    Perform any additional QA tasks, as assigned by QA Manager.

Education / Experience Requirements

•    Excellent communication and presentation skills. Bachelor degree is preferred or the equivalent ASQ Certified Quality Engineer certification. 
•    3+ years of Quality Assurance experience required within medical device / FDA regulated industry preferred. 
•    Bachelor's degree in engineering or equivalent specialized experience with emphasis in Quality.  
•    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

•    Quality Assurance (21 CFR 820, ISO 13485) and Risk Management (ISO 14971) experience required
•    Experience with Corrective Action, Manufacturing and Design Control concepts desired.
•    Computer literate (i.e., statistical software and analysis, excel, word processing for report generation, PowerPoint presentations, etc.).
•    Positive attitude and ability to operate and communicate effectively with multiple teams & leadership.
•    Ability to reason, support and prioritize projects, adapt to shifting priorities, effectively solve problems / conflicts, and proactively effect change.
•    Computer skills, including proficiency with Microsoft Word, Excel, and PowerPoint is required.
•    Problem solving skills and experience with Root Cause Analysis tools (6M, Cause-Effect, 5Ws etc)
•    Good listening, verbal and written communication skills 
•    Excellent interpersonal skills with a demonstrated ability to work in a team environment.
•    Ability to prioritize and adapt to shifting priorities is desired
•    Ability to work independently with limited supervision

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