Quality Engineer 1, Product Quality Assurance

Role Overview

• Supports the Product Quality Assurance team 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.
• 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 is 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 QA Manager and address other items as assigned by Manager.

Requirements

• BS Degree in Engineering (or related technical field)
• 0-2 years 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.

Benefits

• medical, prescription drug, dental and vision insurance
• flexible spending accounts
• participation in 401(k) savings plan
• paid time off benefits such as PTO, short
• and long-term disability and parental leave