Teleflex Mansfield , MA 02048
Posted 2 months ago
Expected Travel: Up to 10%
Requisition ID: 10312
About Teleflex Incorporated
Teleflex is a global provider of clinically effective medical technologies designed to improve the health and quality of people's lives. We apply purpose driven innovation - a relentless pursuit of identifying unmet clinical needs - to benefit patients and healthcare providers. Our portfolio is diverse, with solutions in the fields of vascular and interventional access, interventional cardiology, surgical, anesthesia, cardiac care, interventional urology, urology, emergency medicine and respiratory care. Teleflex employees worldwide are united in the understanding that what we do every day makes a difference. 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 Summary
This position is responsible for performing product inspections, implementing controls, standards, procedures and corrective actions in support of the Teleflex Medical Quality System and manufacturing processes.
Principal Responsibilities
With the direction of the Quality Engineer, this position assists with
Performing inspections and laboratory tests as assigned
Addressing product quality issues and non-conformances
Support process compliance and related documentation
Daily production support
Participate in continuous improvement projects
Specific responsibilities include:
Incoming, in-process, and final inspections
Material testing, analysis, and documentation of results
Identification of non-compliances (product or process) via creation of nonconformances using (NC) process
First article inspections and product/process validation activities
Perform creation and inspection of product identification labels
Support document control activities (Agile updates, work package validation & storage)
Support creation and maintenance of calibration records/plans
Perform Endotoxin testing, Color test and IV lab tests
Support customer complaint investigation activities
Perform Environmental testing including temperature monitoring
Peform Device History Record review and product release activties in SAP
Follow safety, manufacturing and QA procedures and requirements
Education / Experience Requirements
Minimum of a High School Diploma or equivalent required
Minimum of 2 years' vocational training or Associates Degree in a technical field (such as industrial technology) OR a minimum of 3 years' experience working in and industrial environment
Knowledge and experience of working in the medical device industry preferred
ASQ Certification desired
Experience with cGMP, FDA regulations, and ISO Quality Systems, strongly desired
Experience in Lean/Six Sigma techniques preferred
Six Sigma Green Belt preferred
Strong analytical & problem-solving experience (DMAIC, 5Ws, Cause-Effect methods preferred)
Previous participation in 5S events & FMEAs preferred
Minitab and SAP experience preferred
Specialized Skills / Other Requirements
Proficiency in reading and interpreting engineering drawings, specifications, dimensioning & tolerances, procedures and documentation.
Proficiency in use and understanding of measurement & test equipment including an understanding of Gage R&R process.
Excellent math, analytical and problem-solving skills.
Proficient computer skills in Microsoft Office required.
Highly organized self-starter who is detailed oriented with drive and enthusiasm for quality.
Must possess excellent communication skills, both verbal & written.
Must be able to interface directly with employees & internal Teleflex suppliers. "Hands-on" approach towards manufacturing floor involvement.
Ability to work in fast paced, team-oriented work environment.
Knowledge of validation processes highly preferred.
Ability to work as part of an effective team
TRAVEL REQUIRED 0-10 %
Teleflex, Inc. is an affirmative action & equal opportunity employer. D/V/M/F. Applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, affectional or sexual orientation, gender identity or expression, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: 877-880-8588 or Talent@Teleflex.com.
Teleflex is the home of Arrow, Deknatel, Hudson RCI, LMA, Pilling, Rüsch, UroLift and Weck - trusted brands united by a common sense of purpose. Teleflex, the Teleflex logo, Arrow, Deknatel, Hudson RCI, LMA, Pilling, Rüsch, UroLift and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and/or other countries.
Teleflex