Senior Quality Engineer

Position Summary

Focus on driving continuous improvement in 4 main areas of the Quality System in support of corporate Quality objectives:
-Quality & Cost Improvement Projects including Inspection & Test improvement efforts
-Supplier quality management & Improvement
-Validation Process
-CAPA & Nonconformance (NC) Process
Additionally, this position will support operational and engineering activities to ensure product quality and services are achieved, maintained, and improved. Coaching, mentoring and supervision of Associate Quality Engineers or other Quality team members may be assigned and required. 
 

Principal Responsibilities

•    Lead and support Quality improvement projects in support of proactive Quality and CIP initiatives. Primary focus in inspection and test areas and scrap reduction.
•    Refine the validation protocol process with focus on simplification, ease of use and error-proofing. Incorporate Design of Experiments (DOE), process FMEAs and other statistical tools within the validation process. Support or conduct product and/or process qualification following changes to manufacturing processes utilizing validation process.
•    Manage the CAPA and Nonconformance processes involving progress tracking and monitoring; review meetings and effectiveness verification planning to ensure timely and effective completion.
•    Support complaint evaluation on high profile/complex situations.
•    Support and respond to customer inquiries on material environmental assessments such as REACH, RoHS, and Conflict Minerals.
•    Provide QA/QE support to manufacturing as necessary, including product specifications reviews, Material Review Boards, and quality documentation issues.
•    Interface with various internal and external resources such as Manufacturing, Product Development, Marketing, and Customer Care.
•    Conduct and support customer quality and internal quality audits, as required.
•    Adhere to and ensure the compliance of Teleflex’s Code of Ethics, all Company policies, rules, procedures and housekeeping standards.
 

Education / Experience Requirements

•    Minimum of Bachelor’s Degree required. Prefer degree with a technical focus.
•    Minimum of 8 years of Quality or related Manufacturing/Engineering experience in a regulated environment. Prefer previous medical device experience.
•    ASQ Certified Quality Engineer, highly desired.
•    ASQ Certified Quality Auditor, highly desired. 
•    Previous experience with CAPA and Nonconformance management required
•    Previous experience conducting or supporting customer quality and internal quality audits preferred
 

Specialized Skills / Other Requirements

•    Ability to travel domestically and internationally 
•    Ability to define problems, collect data, establish facts, and draw valid conclusions  
•    Ability to identify priorities and meet deadlines in a fluid, demanding environment
•    Knowledge of quality system development, implementation, and verification
•    Planning, controlling and assuring product and process quality ability
•    Ability to apply Lean/Six Sigma and problem-solving skills in a manufacturing environment
•    Understanding and application of reliability and risk management
•    Strong leadership ability
•    Strong understanding and use of quantitative methods
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