QMS Specialist

Teleflex•Mansfield, MA

7d•$52,000 - $72,800

About The Position

As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people’s lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose-driven innovation, and world-class products can shape the future direction of healthcare. Teleflex is the home of Arrow™, Barrigel™, Deknatel™, LMA™, Pilling™, QuikClot™, Rüsch™, UroLift™ and Weck™ – trusted brands united by a common sense of purpose. At Teleflex, we are empowering the future of healthcare. For more information, please visit teleflex.com. OEM – Teleflex Medical OEM is a leading global provider of product development and production services for medical device manufacturers. We set ourselves apart with deep expertise, decades of experience, a dedication to design for manufacturability, and extensive, in-house capabilities, which include engineering, regulatory services, material selection and formulation, prototyping, manufacturing, assembly and packaging. We deliver industry-changing innovations and next-generation solutions for extrusions; diagnostic and interventional catheters; balloons and balloon catheters; sheath/dilator sets; specialty sutures, braids and fibers; and bioabsorbable sutures, yarns and resins. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.Position SummaryUnder guidance of the QMS Lead, this position supports adherence to the quality system, and applicable QSR and ISO standards. First point of contact for quality management and ensuring compliance for Performance Fiber business.

Requirements

Minimum of a High School Diploma or equivalent required
Minimum of 2 years vocational training OR associate degree in a technical field (such as industrial technology) OR a minimum of 3 years’ experience working in an industrial environment
Knowledge and experience of working in the medical device industry preferred.
Advanced level of English, written and oral.
Knowledge of international standards and quality tools.
Ability to adapt to change and address quality nonconformities.
Problem Solving.
Knowledge of MS Office.
Ability to prioritize and work under set deadlines.
Management and interpretation of data.
Highly organized self-starter who is detailed oriented with drive and enthusiasm for quality.
Must possess excellent communication skills, both verbal & written
Ability to work in a fast paced, team-oriented work environment

Responsibilities

Facilitate local process development, implementation, review/approval and maintenance.
Facilitate the maintenance and storage of documentation and records of QMS compliance.
Verify on the job training has been accurately documented, is complete and filed in respective employeesfiles
Perform training of local staff on general management and quality requirements, requirements regulatorycompliance, business processes and use of the quality database.
Communicate QMS compliance issues to Value Stream Management.
Understand internal and external requirements and ensure adherence to them.
Ensure that all QMS compliance, administration and QMS records are completed on time and form and arefiled correctly on the site.
Keep continuous improvement alive at the site level.
Facilitate continuous improvement through leadership in site root cause analysis and non-conformitymanagement conformities.
Promote the use of quality tools and processes.
Act as site liaison for internal Stewardship and QMS audits / quality reviews / periodic evaluations
Oversee compliance with administration/QMS requirements.
Presentation of results at local and regional level.
Reports NCRB, QDAR and other QMS metric to Value Stream Management and BU leadership