Senior Quality Systems Engineer

Teleflex Medical Europe
Employment Type
Not disclosed
Teleflex Medical Europe logo

This position will report to Senior Director, Quality Systems. This position will be based in Athlone

Job Purpose: 

This position is required to improve and support maintenance of the Quality Management System (QMS) at Teleflex ensuring compliance to applicable standards and regulations and in conjunction with business requirements. The role will involve multi-site collaboration with Teleflex Medical offices.

Key Responsibilities:

•Support project management activities for key strategic initiatives including One Quality Management System, and eQMS through roadmap and detail plan creation including communication and change management plan.

•Host workshops to collaborate with Quality System Leads and process map current state of Quality System Elements across the enterprise

•Identify and implement Key Performance Indicators to reflect process effectiveness, speed and efficiency

•Identify workload drivers and complexity factors of Quality System Element Processes

•Host workshops to collaborate with Quality System Leads and develop desired future state accounting for best practices observed across Quality Systems and industry standard practice

•Support process to develop or revise procedures including a gating mechanism

•Support training content and delivery

•Identify/escalate any compliance issues and their potential impact across Teleflex and provide potential solutions/actions so that they can be effectively resolved.

•Interface with all sites and site stakeholders for QMS Architecture questions

•Analyse Key Performance Indicators across the Enterprise to ensure process compliance 

•Identify, propose and lead continuous improvement opportunities as it relates to the QMS architecture

•Lead or support additional local or global projects as assigned by Quality and Regulatory Leadership

Essential Skills / Experience:

•Bachelor’s degree in a relevant Engineering discipline or equivalent.

•7 years of experience in quality or compliance working in a multi-site company in the Medical Device industry. 

•Experience with Quality Management Systems. Strong knowledge of FDA 21 CFR, EU Medical Devices Regulation and other global medical device regulations and standards, including but not limited to International standards ISO 13485, ISO 14971.

Other Skills / Experience:

•Project Management Experience as project sponsor or lead

•Experience with electronic Quality Management System (eQMS) implementation

•Demonstrated strong expertise with developing and leading Strategic improvement plans to business process flows.

•Experience working in Quality Operations environment

•Experience and/or ability to manage cross-functional team meetings; train or coach other employees; and give presentations.

•The ability to establish rapport with internal and external customers, peers, and employees in all departments.

•Excellent organizational skills.

•Excellent written and verbal communication skills.

Behaviours/ Values: 

•Approachable and enthusiastic.

•Flexible and adaptable.

•Able to work on own initiative and as a team player.

•Excellent organisational skills with cultural awareness and sensitivity

•Excellent judgment and problem solving ability & is capable of understanding the impact of decision making on both Teleflex Medical and their customers.

Key Relationships / Interfaces:

•Sr. Director Global Quality Systems

•Quality Assurance

•Regulatory Affairs

Travel Required: 15%

Note: As with all positions, due to the dynamic nature of Teleflex Medical business, key responsibilities will evolve and change over time. Teleflex is an equal opportunities employer.