Senior Quality Engineer

Position Summary

The Sr. Quality Engineer will be responsible for cross-functional quality assurance, quality management/compliance, quality control, and activities associated with all Teleflex products and processes with a focus on manufacturing activities.  In support of Corporate Quality Objectives, the incumbent will lead, manage, and drive improvement in 5 main areas of the Quality Management System including CAPA & Nonconformance (NC) Processes; Incoming Inspection Improvements; Perpetual Audit readiness; Product Complaints identified as manufacturing related; and Quality Improvement efforts related to Global or Local initiatives, such as Cost Improvement Projects.  Additionally, the Sr. Quality Engineer will support the Operations, Engineering, R&D, and Post Market Surveillance team activities to ensure that product quality and services are achieved and maintained.

Principal Responsibilities

•    Nonconformance (NC) and CAPA processing – lead quality activities such as inspection methods, NC containment, correction, closure and CAPAs; and drive improvement through analysis of trend data. 
•    Post market compliant processing – including risk evaluations and investigations
•    Support Incoming & In-Process Inspection teams.
•    Prepare QSRB and QMR slides as needed.
•    Support the Value stream with investigations required for field corrective actions including risk evaluation.
•    Perform internal audits and support supplier corrective actions as needed.
•    Quality & Cost Improvement Projects – lead and participate in key short-term projects on product or process improvements.
•    Production & Process Controls – review, change and approve manufacturing procedures; test method validations; Quality Inspection plans and Process run sheets. 
•    Auditing – routinely perform internal and process-related audits. Participate in vendor audits if necessary. Support the Back Room during regulatory and notified body audits. 
•    Documentation Control – perform change controls (ADC/ECOs) as needed. 
•    Training – Perform QA training certifications on new production operators as needed.
•    Support Engineering with new product development with quality planning, risk evaluation, and validation. 
•    Perform any additional QA tasks, as assigned by QA Manager or Plant Manager. 
•    Maintain compliance with Teleflex Global & local procedures and policies.
•    This position requires direct contact with an implantable device.      ☐ Yes     ☒ No 
•    Other duties as assigned.
 

Education / Experience Requirements

•    Minimum 4-year degree in an Engineering discipline – Mechanical, Biomedical, Plastics, Industrial, etc. 
•    ASQ Certified Quality Engineer or Certified Quality Auditor preferred. 
•    Minimum 5 years experience of Quality and/or related Manufacturing/Engineering experience in a manufacturing site with the following skills:
•    CAPA, Nonconformance and MRB lead or management role.
•    Planning, controlling and assuring product and process quality .
•    ISO 13485 regulation knowledge and experience with MDSAP; certification is preferred
•    Medical Device Complaint Handling.
•    Quality System management and deployment experience.
•    Risk management
•    Problem-solving and quality improvement, including quantitative methods.
•    Design Controls
•    Validations (product and process IQ/OQ/PQ).
•    Supplier Quality Engineering (i.e. Supplier Audits, Inspection Techniques).
 

Specialized Skills / Other Requirements

•    MDSAP experience (backroom/front room/Subject Matter Expert); Supplier Audits; Internal Audits; Calibration; QA and Incoming Inspection. 
•    Knowledgeable of ISO 13485, ISO 14971, and FDA QSR requirements.
•    Computer skills, including proficiency with Microsoft Word, Excel, and PowerPoint is required. 
•    Working knowledge and/or experience with SAP and AGILE is strongly preferred.
•    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.

TRAVEL REQUIRED: 0-10%
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