Quality Management Systems Specialist (Coventry)
Date: Nov 14, 2023
Location: Coventry, CT, US
Company: Teleflex
Expected Travel: Up to 10%
Requisition ID: 9369
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
Under the guidance of the Quality Engineer, 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.
Principal Responsibilities
• Facilitate local process development, implementation, review/approval and maintenance.
• Facilitate the maintenance and storage of documentation and records of QMS compliance.
• Lead on the job training for production employees and training of local staff on general management and quality requirements, requirements regulatory compliance, 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 are filed correctly on the site.
• Keep continuous improvement alive at the site level.
• Facilitate continuous improvement through leadership in site root cause analysis and non-conformity management 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 metrics to Value Stream Management and BU leadership.
Education / Experience 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 detail-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.
The pay range for this position at commencement of employment is expected to be between $58,700-$88,100, however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position will also include benefits such as medical, prescription drug, dental and vision insurance, flexible spending accounts, participation in 401(k) savings plan, and various paid time off benefits, such as PTO, short- and long-term disability and parental leave, dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.
If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
TRAVEL REQUIRED 0-20 %
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Specialized Skills / Other Requirements
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.