Quality Systems Specialist - Operations Excellence Support
Teleflex

Job Info

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Quality Systems Specialist - Operations Excellence Support

Long Description

Position Summary

Principal Responsibilities

Education / Experience Requirements

Specialized Skills / Other Requirements

POSITION SUMMARY :

Growth, Culture, People and Careers: this is the Teleflex Advantage.

In this exciting role as a Quality Systems Specialist, you will have responsibility for supporting as required in all Quality related activities in the North American Distribution Center (NADC). This position will be a key liaison between quality and operations.

This position provides Quality Engineering support to the Quality Management System for the Chelmsford site. The primary purposes and objectives include:

• Nonconformance and Corrective & Preventive Action coordination and processing.
• Provide input and gather data for the monthly Quality System Review Board (QSRB).
• Provide input and gather data for the quarterly Quality Management Reviews (QMR).
• Support the Value Stream on NC and CAPA investigations.
• Internal & external auditing responsibilities and support.
• Support the training department as needed.
• Quality improvement projects
• Maintain compliance with Teleflex Global & local procedures and policies.

PRINCIPAL RESPONSIBILITIES :

• Nonconformance (NC) and CAPA processing - support quality activities such as inspection methods, NC containment, correction, closure and CAPAs; and drive improvement through analysis of trend data.
• Prepare QSRB and QMR slides as needed.
• Perform internal audits and support supplier corrective actions as needed.
• Quality & Cost Improvement Projects - lead and participate on key short-term projects on product or process improvements.
• Auditing - routinely perform internal and process-related audits. Support the Back Room during regulatory and notified body audits.
• Documentation Control - perform change controls (ADC/ECOs)
• Operations - dedicated support for NADC wave planners for QA
• Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.
• Maintain site Board of Pharmacy Certification requirements
• Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Perform any additional QA tasks, as assigned by QA Manager or QA Supervisor

This position requires direct contact with an implantable device. Yes No

EDUCATION/EXPERIENCE REQUIREMENTS :

Must Have: Minimum Requirements

To be considered for this role, please ensure the minimum requirements are evident on your resume.

• Knowledge of QSR, CFR, cGMP, and ISO regulations (required)
• Computer skills, including proficiency with Microsoft Word, Excel, and PowerPoint is required.
• Working knowledge and/or experience with SAP and AGILE strongly preferred.
• Statistical Techniques preferred (DOE, SPC, and Gage R&R).
• 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.
• Ability to speak and read Spanish is preferred for future growth.

TRAVEL REQUIRED : None

WORKING ENVIRONMENT:

Office/Professional Plant/Manufacturing

This job has expired.