Quality Engineer II

6 days ago


Chelmsford, United States Teleflex Full time
Position Summary

The Quality Engineer II 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 contribute, 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 Quality Engineer II 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. 
• Support Incoming & In-Process Inspection teams.
• Support the value stream with investigations required for field corrective actions including risk evaluation.
• Participate in internal audit activities and support supplier corrective actions as needed. Participate in vendor audits if necessary. Support the Back Room during regulatory and notified body audits.
• Production & Process Controls – review, change and approve manufacturing procedures; test method validations; Quality Inspection plans and process run sheets. 
• Documentation Control – perform change controls (ADC/ECR/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. 
• Maintain compliance with Teleflex Global & local procedures and policies.
• This position requires direct contact with an implantable device. ☐ Yes ☒ No 

Education / Experience Requirements

• Minimum 4-year degree in an engineering discipline – Mechanical, Biomedical, Plastics, Industrial, etc. 
• Minimum 2-3 years experience of quality and/or related manufacturing/engineering role, prefferably in a manufacturing site.
• Quality system management and deployment experience preferred.
• Problem-solving and quality improvement, including quantitative methods.
• Validations (product and process IQ/OQ/PQ).

Specialized Skills / Other Requirements

• 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.
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