Quality Engineer III

Position Summary

This position provides quality assurance and engineering leadership for process development and manufacturing. 

The primary purposes and objectives include:
•    Nonconformance/CAPA coordination and processing 
•    Customer complaint investigations
•    Process & product validations
•    Customer notification of change evaluations
•    Internal & external auditing responsibilities and support
•    Supplier quality issues and change support
•    Lead Quality improvement projects
•    Maintain compliance with Teleflex Global & local Procedures and Policies

Coaching, mentoring and supervision of other quality personnel may be assigned and required.
 

Principal Responsibilities

•    Nonconformance (NC) and CAPA ownership and participation
•    Customer Complaint ownership and participation; Act as primary customer contact on complaint communications. 
•    Process Validations – guide and review protocol development, validation implementation and report review an acceptance.
•    Quality & Cost Improvement Projects – lead and participate in product and/or process improvement projects. 
•    Production & Process Controls – review, change and approve Manufacturing Procedures; Test Method validations; equipment qualifications, Quality Inspections and more to ensure product confirms to specifications. 
•    Auditing – routinely perform internal and process related audits. Participate in supplier and customer audits as necessary. Support the Back Room during FDA and Notified Body audits. 
•    Documentation Control – perform document reviews and updates, including ownership of Engineering Change Notices as needed.
•    Supplier Quality – provide support on incoming material quality, on NCs and Supplier Corrective Actions (SCARs). Also participate in evaluation of any supplier or supplier material changes (SCNs).
•    Training – Perform QA training certifications on new Production operators.
•    Support Engineering with New Product Development with planning, risk evaluation, controls, validation and more to help with successful product transfer into manufacturing.  
•    Perform any additional QA tasks, as assigned by QA Manager or Plant Manager. 
•    Other duties as assigned. 
 

Education / Experience Requirements

•    Minimum of Bachelor degree required. Degree in a related field or technical focus, preferred. 
•    Minimum of 5 years of QA or engineering experience, required. 
•    Experience in a manufacturing environment, regulated or medical industry preferred.  

Additional experience and proven success in the following area or skill is preferred: 
•    CAPA and Nonconformance process
•    Customer Complaint Investigations
•    Validation concepts & techniques (process, equipment, and test methods)
•    Continuous Improvement Process/Project Management
•    Process or internal auditing.
 

Specialized Skills / Other Requirements

•    Regulatory, CFR, cGMP, QSR and ISO 13485 knowledge base
•    Problem solving skills and experience with Root Cause Analysis tools 
•    Statistical Techniques and experience with Minitab desired 
•    Competent in MS Word, Excel, & PowerPoint. SAP ERP knowledge is a plus.
•    Good oral and written communication skills 
•    Ability to prioritize and work independently with limited supervision
•    Ability to adapt to shifting priorities
•    Excellent interpersonal skills with a demonstrated ability to work in a team environment.
•    ASQ Certified Quality Auditor highly desired
•    Design Control and Risk Management experience desired.
 

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