Quality Engineer 1, Product Quality Assurance

Teleflex•Durham, NC

About The Position

Teleflex is seeking a Quality Engineer 1 to support its Product Quality Assurance team by analyzing post-market data and potential quality issues involving commercialized medical devices. The role handles a broad range of technical Quality Assurance assignments under general supervision and works with cross-functional investigation teams. The position applies fundamentals of root-cause investigation, risk management, and medical-device quality management systems, including 21 CFR 820, ISO 13485, and ISO 14971.

Requirements

Bachelor of Science degree in Engineering or a related technical field.
0–2 years of related experience; medical-device experience is preferred.
Computer literacy, including statistical software and analysis, Excel, word processing for report generation, and PowerPoint presentations.
Positive attitude and ability to operate and communicate effectively with multiple teams and leadership.
Ability to reason, support and prioritize projects, adapt to shifting priorities, solve problems and conflicts effectively, and proactively effect change.
Understanding of root-cause investigation, risk management, and medical-device quality management systems per 21 CFR 820, ISO 13485, and ISO 14971.

Nice To Haves

Medical-device industry experience.

Responsibilities

Create, investigate, and/or manage nonconformances, including associated ship holds and product disposition.
Investigate, compile, and report information for executive management to assess whether field actions, corrections, or removals associated with Teleflex products are warranted.
Work with Manufacturing sites, R&D, Suppliers, Supplier Quality, Marketing, Design Assurance, and Regulatory to investigate and document quality issues.
Assist with compiling and analyzing product quality metrics for presentation to Global and business unit leadership.
Use basic statistical techniques to identify rates, trends, or estimated occurrences based on bench and field data.
Prepare clear, concise technical reports and support external communications as needed to respond to product quality issues.
Assist during regulatory inspections and/or audits as required.
Use SAP, Agile, and other applicable systems for data input and quality-record maintenance.
Communicate and escalate Quality issues appropriately to the QA Manager and address other items assigned by the Manager.
Comply with the Teleflex Code of Ethics and all company policies, rules, and procedures.
Demonstrate commitment to goals, continuous improvement, and the company’s culture and values.