Quality Engineer, Product Quality Assurance

Position Summary

Supports the Product Quality Assurance team in 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.

Principal Responsibilities

• Work closely with Manufacturing sites, R&D, Suppliers, Supplier Quality, Sterilization, and Regulatory to investigate and document quality issues.
• Assist with compiling and analyzing 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 SAP, Agile, and other systems as warranted for data input and quality record maintenance.
• Investigate, compile, and report on information necessary for executive management to assess if field actions/corrections and removals associated with Teleflex products are warranted.
• Utilize sound technical writing to provide clear and concise written internal reports and support external communications as needed to respond to Product Quality issues.
• Create, investigate, and/or manage nonconformances, as well as associated ship holds and product disposition.
• Communicate and escalate Quality issues appropriately to QA Manager and address other items as assigned by Manager
• Assist during regulatory inspections and/or audits as required.

Education / Experience Requirements

• BS Degree in Engineering (or related technical field)

Specialized Skills / Other Requirements

• 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