Quality Engineer 1, Product Quality Assurance

About the Role

Supports the Product Quality Assurance team by analyzing post-market data and potential product quality issues for commercialized devices. Accountable for a broad range of technical assignments in the Quality Assurance area under general supervision and working with cross-functional investigation teams. Understands the fundamentals of root cause investigation, risk management, and medical device Quality Management Systems per 21 CFR 820, ISO 13485, and 14971.

Key Responsibilities

• Create, investigate, and/or manage nonconformances, as well as associated ship holds and product disposition.
• Investigate, compile, and report on information necessary for executive management to assess if field actions/corrections and removals associated with Teleflex products are warranted.
• Work closely with Manufacturing sites, R&D, Suppliers, Supplier Quality, Marketing, Design Assurance, and Regulatory to investigate and document quality issues.
• Assist with compilation and analysis of product quality metrics for presentation to Global and business unit leadership.
• Utilize basic statistical techniques to identify rates, changes in trends, or estimated occurrences based on bench and field data.
• Utilize sound technical writing to provide clear and concise written internal reports and support external communications as needed to respond to Product Quality issues.
• Assist during regulatory inspections and/or audits as required.
• Utilize SAP, Agile, and other systems as warranted for data input and quality record maintenance.
• Communicate and escalate Quality issues appropriately to the QA Manager and address other items as assigned by the Manager.

Requirements & Tech Stack

• BS Degree in Engineering (or a related technical field)
• 0-2 years of related (medical device preferred) experience
• Computer literate (i.e., statistical software and analysis, Excel, word processing for report generation, PowerPoint presentations, etc.).
• Positive attitude and ability to operate and communicate effectively with multiple teams & leadership.
• Ability to reason, support and prioritize projects, adapt to shifting priorities, effectively solve problems/conflicts, and proactively effect change.

Travel

• Expected Travel: Up to 10%