Supplier Quality Engineer

Date: Jan 5, 2023

Location: Mansfield, MA, US

Company: Teleflex

Expected Travel: Up to 25%

Requisition ID: 7422

 

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 ensuring the quality of all raw materials used in support of Performance Fibers Manufacturing Operations and championing any corrective or improvement efforts with suppliers. This position is also responsible for managing any notification of changes issued by suppliers and working with appropriate departments to perform any identified activities associated with supplier controls or supplier change notifications  
The SQE shall report and maintain Supplier KPIs, identify material improvement efforts and drive the implementation of supplier risk reduction and continuous improvement objectives. The SQE must be capable of leading supplier audits in accordance with Teleflex and ISO 13485 standards.
 

Principal Responsibilities

•    Lead Supplier Qualification activities for new suppliers and remediate existing supplier files to comply with Teleflex Global and Site level requirements.
•    Report Supplier Quality metrics to Global on a weekly and monthly basis to monitor supplier performance.
•    Conduct meetings on a monthly/quarterly basis to review supplier scorecards and performance and implement necessary action based on the performance.
•    Lead any Supplier Quality Improvement Objectives in support of Global and local Quality Objectives. 
•    Lead and manage supplier-related Non-Conformances (NC) and Supplier Corrective Action Processes (SCAR) with a focus on timely response; adequate root cause analysis methods; and effective corrective/preventative actions.  
•    Support Material Review Board (MRB) with regard to supplier-identified in-process Nonconformance Reviews. 
•    Provide support to incoming inspections and establish disposition plans for quarantined raw material. 
•    Effectively partners with suppliers to ensure products conform to specifications and quality standards while driving continuous improvement with suppliers.
•    Supports the R&D and purchasing departments with the identification and selection of vendors in the new product development process.
•    Drive improvements in the overall material supply process thru FMEA/risk-based incoming inspection processes; supplier KPI monitoring, supplier audits and continuous improvement projects. 
•    Manage the Supplier Change Notification (SCN) process through evaluation and assessment of proposed changes at suppliers and provide support to applicable departments with any planned change management.
•    Systematically monitor risk in supply chain through standardized Supplier metrics, new vendor approval process, and onsite assessments. Escalate any risk issues to Product Development and/or management with a proposed risk reduction plan(s). 
•    Direct communication with suppliers on quality issues and with applicable departments through proactive relationships.
•    Lead efforts to continuously improve raw material quality, while ensuring safety, efficacy, and regulatory compliance. 
•    Utilize Incoming Quality Inspector and key Operations, Engineering and QE resources as partners in meeting Supplier Quality Objectives. 
•    Participates in continuous improvement projects and other quality engineering activities when needed.
 

Education / Experience Requirements

•    Bachelor’s degree (scientific, technical, or engineering) is preferred with 2 years of QA or QE experience
•    Minimum of 1-year experience in the medical device field preferred
•    Experience in a manufacturing setting with a proven track record of successful performance is desired.
•    CSQP certification is highly desired
 

Specialized Skills / Other Requirements

Additional experience and/or proven success in the following areas or skills:
•    Supplier quality management processes including Supplier Corrective Actions (SCAR), First Article Inspection (FAI), Incoming Inspection Plans (IP), and supplier audits.
•    Supplier auditing; ISO Lead Auditor certification desired. 
•    Continuous Improvement Process
•    Project Management skills, desired
•    Regulatory cGMP, QSR and ISO knowledge base. ISO 13485 & FDA regulations (such as 21 CFR 820, 210) is preferred. 
•     Proficient with Microsoft Office.  (Outlook, MS Word, Excel, Access, PowerPoint, and Mini-tab preferred)
•    Strong negotiation and problem-solving skills
•    Good oral and written communication skills & ability to work with external suppliers and internal stakeholders.
•    Statistical Skills (DOE, SPC, Reliability, Gage R&R)
•    Experience with risk analysis methodologies
•    Strong reasoning ability to support and prioritize projects, adapt to shifting priorities, work with minimal supervision and ability to resolve problems / conflicts

TRAVEL REQUIRED: 10-30%

 

 

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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: 262-439-1894.

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.

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