Sr. Quality Assurance Manager

Position Summary

As part of the Teleflex Global Operations Division, and as a member of the Chelmsford Leadership Team, the Sr. Quality Assurance Manager is responsible for managing the site’s overall quality system in alignment with the company’s global policies.  The Sr. Quality Assurance Manager drives the execution of deliverables by proactively managing a high-performance team while identifying and addressing quality issues and monitoring and reporting the site’s quality metrics, and effectively organizing and leading external audits. This position will work cross-functionally with a variety of departments including the Post Market Surveillance Team to manage and address customer complaints.

Principal Responsibilities

•    Lead the Quality Assurance Team, which includes Quality Engineering, Quality Systems, Quality Control, and Calibration. 
•    Manage a team of Quality professionals in driving robust problem-solving, non-conformance reduction, and continuous improvement efforts. Drive values stream optimization through the application of proven methodologies such as Six Sigma, LEAN, Kaizen events, etc.
•    Promote production line value stream characterization and optimization efforts. Ensure process control plans (SPC, sampling, inspection methods) are appropriate and effective.
•    Proactively manages performance and team dynamics to ensure a fair, professional, and high-performance environment, in alignment with the company’s goals and core values. 
•    Develops individual and organizational capabilities to build bench strength while delivering results.
•    Establish, implement, and maintain an effective, efficient, and cohesive site-specific quality system that ensures compliance with FDA and ISO expectations, in alignment with the company’s global policies. 
•    Responsibility to serve as Management Representative.
•    Organize, lead, and facilitate FDA and Notified Body audits, inspections, and correspondence.
•    Create an internal audit schedule and ensure timely execution.
•    Drive pragmatic, responsive, and timely execution of Non-Conformances and CAPAs.
•    Manage and report on-site quality metrics – monitoring, planning, and executing to improve performance.
•    Identify and respond to trends and quickly address underperforming metrics.
•    Partner with Design Teams to ensure the successful transfer of new designs from development to production.
•    Partner with Operations to maintain supply continuity, execute validations and drive continuous improvement.
•    Support Supplier Quality in the execution of supplier audits, additions, changes, and requests.
•    Support Post Market in complaint investigations, risk assessments, and field actions.
•    Identify, execute, and collaborate cross-functionally on manufacturing scrap and cost reduction projects.
•    Identify, drive, and support optimization and harmonization opportunities to increase effectiveness and efficiency.
•    Provide input into regional and corporate strategic initiatives and execute them at a site level.
•    Execute and make decisions with limited supervision; quickly and clearly escalate issues as appropriate. 
•    Other duties as assigned.
 

Education / Experience Requirements

•    B.S. Degree in Engineering or Physical Sciences required. Master’s Degree or MBA preferred.
•    Minimum of 5 years related quality experience in a manufacturing environment.
•    Minimum of 2 years of experience supervisory or management experience.
•    ASQ CQA or CQE certification preferred.
•    Broad engineering experience in manufacturing operations including new product development, cost reduction, and quality engineering.
•    Knowledge of clean room controls, medical device development, and device assembly.  
 

Specialized Skills / Other Requirements

TRAVEL REQUIRED: Up to 10%

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Working Conditions / Physical Demands

WORKING ENVIRONMENT:
☒ Office/Professional        ☒ Plant/Manufacturing    ☐ Remote/Field     ☐ Laboratory