Value Stream Quality Manager

Position Summary

Leads the assigned manufacturing Value Stream (VS) Quality function ensuring robust, complaint, and efficient delivery on quality and regulatory requirements, through all phases of Customer, product and process lifecycle across multiple manufacturing lines. 

Principal Responsibilities

•    Key responsibilities will include (but are not limited) to the following
•    Driving QMS and Customer Quality requirements throughout product and process lifecycle including NPI, Commercialization, post release feedback and support, Sustaining and End of Life.
•    Managing and developing the VS Quality team to assure consistent application of quality standards and regulatory compliance, audit readiness and Customer satisfaction.  
•    Collaborates closely with Value Stream manufacturing and engineering leadership, other cross-functional teams, to drive operational efficiency while fostering a culture of quality delivery, accountability, continuous improvement, and customer focus.
•    Oversee implementation and execution of Quality Management Systems (QMS), requirements within the assigned VS including Product realisation and release processes, Audits, CAPA, nonconformance investigations, document control, risk management, and change control processes.
•    Ensure all manufacturing processes are verified or validated, monitored, and maintained in a state of control, meeting requirements under Customer requirements, FDA 21 CFR 820, ISO 13485, and other applicable regulations.
•    Develop and monitor key performance indicators (KPIs) for quality execution and support Customer Satisfaction driving Continuous Process Improvement.
•    Analyse quality performance metrics and trends to proactively identify risks, drive root cause investigations, and implement effective corrective and preventive actions.
•    Champion a Quality culture of Customer focus, and proactively identifying and implementing process improvements and quality best practices across the VS
•    Ensure quality initiatives are aligned with business priorities and support overall operational execution and performance.
•    Builds relationships with key stakeholders in the company and addresses their needs of communication and information requests
•    Develop strong customer relationships through professional, constructive, proactive communication on product, process and system quality requirements including change notifications and responsiveness to quality concerns.
•    Support customer audits and inquiries, ensuring timely and accurate responses.
•    Build, mentor, and lead a high-performing Quality team fostering within and cross VS collaboration, accountability, and professional development.
•    Quality lead on multi/cross functional project teams to achieve milestones and results as assigned 
•    Owns and drives the Safety/Quality/Service/Cost Metric for the VS.
•    Leads by example and demonstrates to agreed behaviours.
•    Aligns the goals and objective setting for the VS in collaboration with management
•    Is committed to develop, coach, motivate self and team.
•    Ensure Quality and EHS policies and procedures are adhered to at all times.

Education / Experience Requirements

•    Bachelor’s degree in Engineering, Life Sciences, or a related technical field 
•    Advanced degree such as M.S. or M.B.A preferred.
•    8+ years of progressive experience in quality roles within the medical device industry, 
•    5+ years of leadership or management experience, including direct supervision of teams.

Specialized Skills / Other Requirements

People 
•    Ability to lead meetings
•    Ability to work in a cross functional team
•    Interviewing skills
•    Ability to influence employees that do not report directly

Strategy 
•    Understand the impact of their job on the key business drivers.
•    Basic understanding of other department’s impact on the key drivers and how all departments fit together.

Customers and Vendors 
•    Ability to generate appropriate relationships with customers and vendors
•    Ability to deal with difficult customer or vendor communications
•    Ability to influence customers/vendors where necessary

Teleflex Specific Competencies
•    Ability to work in a fluid, demanding environment
•    Understanding and appreciation of Teleflex ethics standards
•    Thorough understanding of Teleflex processes and products

WORKING ENVIRONMENT:
☒ Office/Professional   

#LI-PD1
#LI-Hybrid