Quality Engineer 1, Product Quality Assurance
Teleflex
Summary
Teleflex is seeking a Quality Engineer 1 to join our team! This role 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.
Job description
Position Summary
Teleflex is seeking a Quality Engineer 1 to join our team! This role 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.
Principal 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 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.
- Adhere to and ensure compliance with the Teleflex Code of Ethics, all company policies, rules, and procedures.
Education / Experience Requirements
- BS Degree in Engineering (or related technical field).
- 0-2 years related (medical device preferred) experience.
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.
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.
Company overview
Teleflex Incorporated is a global medical technology company headquartered in Wayne, Pennsylvania, that specializes in designing, developing, manufacturing, and supplying single-use medical devices for critical care and surgical applications. Founded in 1943, the company has evolved from its origins in precision mechanical controls to become a leading provider of innovative medical technologies. Teleflex serves healthcare providers in over 150 countries through a diverse portfolio that includes solutions in anesthesia, emergency medicine, interventional cardiology and radiology, surgical procedures, vascular access, and urology. The company's well-known product brands include Arrow, Deknatel, LMA, Pilling, QuikClot, Rüsch, UroLift, and Weck. With approximately 14,000 employees worldwide, Teleflex operates 11 manufacturing facilities and 23 distribution centers across the globe. The company focuses on purpose-driven innovation to address unmet clinical needs, aiming to improve patient outcomes, enhance provider safety, and reduce procedural costs while maintaining a strong commitment to quality and corporate social responsibility.