Quality Engineer 1, Product Quality Assurance

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.

INDIVIDUAL CONTRIBUTORS: Core competencies of all roles
•    Commitment to Goals –A strong commitment to achieving goals is essential for personal and team success. It requires taking ownership of tasks, staying focused on priorities, and consistently delivering high-quality work. Being proactive, managing time effectively, and seeking support when needed are critical to meeting deadlines and overcoming challenges. By aligning personal efforts with team and organizational objectives, individual contributors play a vital role in driving results and advancing shared goals.

•    Continuous Improvement - Continuous improvement means actively seeking ways to enhance your work, skills, and contributions. It's critical to stay curious, embrace feedback, and look for opportunities to streamline processes or solve problems more effectively. Individual contributors should take initiative to learn from experiences, adapt to change, and apply new knowledge to drive better outcomes. By consistently striving to improve, they add value to their team and support the organization’s growth and success.

•    Culture and Values – Living our culture and values is essential to fostering a positive, collaborative work environment. Individual contributors demonstrate this by treating others with respect, acting with integrity, and contributing to an inclusive and supportive team culture. It's critical to hold oneself accountable, align actions with shared values, and support the broader mission of the organization. By consistently modeling these behaviors, individual contributors help strengthen the workplace culture and positively influence those around them.

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Working Conditions / Physical Demands

TRAVEL REQUIRED: Up to 15%

WORKING ENVIRONMENT:
☒ Office/Professional        ☐ Plant/Manufacturing    ☐ Remote/Field     ☐ Laboratory

TELEFLEX QUALITY BEHAVIORS:
As a member of the QARA team, you play a critical in our mission to improve the health and quality of people’s lives. Below are the quality behaviours that we expect all QARA employees to exhibit every day.

Patient Focused
•    We prioritize our patients and users in our decision making. 
•    We understand our products and recognize our actions affect product quality. 
•    We understand the impact of product quality on user and patient safety. 
Accountable
•    We show up prepared and if we say we'll do it, we do. 
•    We learn from mistakes and address them quickly.
•    We speak up and take responsibility.                                         
Preventive
•    We proactively look for and address things that could go wrong. 
•    We speak up when we notice poor quality. 
•    We correct poor quality and prevent recurrence.  
Solution Minded
•    We bring solutions to identify problems and are open to change.  
•    We share and implement ideas to continuously improve. 
•    We evaluate fully and investigate to root cause.