Quality Systems Analyst

Date: Jul 13, 2024

Location: Chelmsford, MA, US

Company: Teleflex

Expected Travel: Up to 10%

Requisition ID: 10526

 

About Teleflex Incorporated

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™, QuikClot™, LMA™, Pilling™, 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.

 

Global Operations - Global Operations is a complex and diverse organization within the company which is responsible for product fulfilment to all our customers from end to end. We pride ourselves on being totally Customer Centric in our unrelenting focus on Improving Quality, Service and Value as perceived by our customers. Our employees are dedicated to the Global Operations Enterprise Excellence journey. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.

Position Summary

The Quality Systems Analyst (QSA) will be responsible for coordinating and managing nonconformance activities and deliverables within the quality system. This role will also support other quality system elements including training curriculum management, document analyst responsibilities, and audit participation. The ideal candidate will have a strong background in quality assurance, particularly within the medical device industry, and possess excellent organizational and communication skills. Additionally, the QSA assists in special projects aimed at reducing waste and optimizing resources in quality systems and processes. The QSA interacts with different areas of the organization at a local, regional, and global level to meet the objectives and indirectly leads activities.

Principal Responsibilities

The key areas of responsibilities are:

•    Nonconformance processing- lead quality activities such as NC containment, correction, and closure; drive improvement through analysis of trend data
•    Coordinate and manage nonconformance reports (NCRs) and related activities.
•    Ensure timely investigation, documentation, and resolution of nonconformance issues.
•    Work collaboratively with cross-functional teams to identify root causes and implement corrective and preventive actions (CAPA).
•    Monitor and track nonconformance trends and report findings to management.
•    Assist in the development, implementation, and maintenance of the quality management system (QMS) in compliance with regulatory requirements (e.g., FDA, ISO 13485).
•    Coordinate and manage the training curriculum for employees, ensuring compliance with quality system requirements.
•    Analyze and review quality system documents to ensure accuracy, completeness, and compliance.
•    Participate in internal and external audits, providing support and documentation as needed.
•    Assist in the preparation and review of audit reports, ensuring timely follow-up on corrective actions.
•    Assist in the collection, analysis, and reporting of quality metrics.
•    Prepare and distribute regular quality metric reports to management.
•    Monitor key performance indicators (KPIs) to identify trends and areas for improvement.
•    other duties as assigned.
 

Education / Experience Requirements


•    Minimum of 2-3 years’ experience in Quality Assurance experience required.
•    Experience in a manufacturing environment, with preference in a regulated or medical industry.
•    Critical thinker with a comprehensive understanding of regulatory requirements, risk management principles and science-based decision making
•    Strong computer skills including Microsoft Office 
•    Key competencies in verbal and written communication; attention to detail
 

Specialized Skills / Other Requirements

•    Computer skills, including proficiency with Microsoft Word, Excel, and PowerPoint is required.
•    Working knowledge and/or experience with SAP and AGILE strongly preferred.
•    Problem solving skills and experience with Root Cause Analysis tools (6M, Cause-Effect, 5Ws etc)
•    Good listening, verbal, and written communication skills
•    Excellent interpersonal skills with a demonstrated ability to work in a team environment.
•    Ability to prioritize and adapt to shifting priorities.
•    Ability to work independently with limited supervision.
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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, 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.


Nearest Major Market: Boston