Quality Engineer 1, Product Quality Assurance

Teleflex; Chelmsford (MA); On-site; USD 72,000 - 108,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) savings plan

Paid time off

Job summary

Teleflex, a global provider of medical technologies, is seeking a Quality Engineer 1 for Product Quality Assurance. The role supports the QA team by analyzing post-market data and addressing product quality issues in accordance with 21 CFR 820, ISO 13485, and 14971. Includes investigation, data analysis, and cross-functional collaboration with Manufacturing, R&D, and Regulatory.

Requires a BS in Engineering and 0-2 years of related experience. SAP and Agile experience are a plus.

Qualifications

• BS Degree in Engineering (or related technical field).
• 0-2 years of related experience in medical devices preferred.
• Proficient with statistical analysis and MS Office suite (Excel, PowerPoint).

Responsibilities

• Create, investigate, and/or manage nonconformances and related ship holds and product disposition.
• Investigate, compile, and report information for executive review of field actions and removals.
• Collaborate with Manufacturing, R&D, Suppliers, Supplier Quality, Marketing, Design Assurance, and Regulatory.
• Assist with compiling and analyzing product quality metrics for leadership.
• Apply basic statistical techniques to identify trends and occurrences from data.
• Prepare clear internal reports and support external communications on quality issues.
• Assist during regulatory inspections and audits as needed.
• Utilize SAP, Agile, and other systems for data input and quality record maintenance.
• Communicate quality issues to the QA Manager and assist with other tasks as assigned.

Education

BS Degree in Engineering

Tools

SAP

Agile

Job description

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Quality Engineer 1, Product Quality Assurance

As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people’s lives. Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology. We believe that the potential of great people, purpose-driven innovation, and world-class products can shape the future direction of healthcare.
Acute Care - The Acute Care division of Teleflex is dedicated to empowering healthcare professionals with industry-trusted devices that advance the practice of anesthesia and respiratory care. Our portfolio includes LMA™ Airways, Rüsch™ Laryngoscopes, Rüsch™ and Sheridan™ Endotracheal Tubes, and Arrow™ Pain Management—products designed to provide reliability, performance, and clinical value. Built on a foundation of quality and innovation, our solutions support clinicians across a wide range of care settings, including emergency prehospital environments, hospitals, and procedural settings. Each product is developed with a focus on patient safety, ease of use, and consistency, helping providers respond effectively to evolving clinical demands. Join a dynamic, growing team that offers healthcare providers advanced medical technology solutions that make a difference in patients' lives.
Teleflex is the home of Arrow™, Barrigel™, Deknatel™, LMA™, Pilling™, QuikClot™, Rüsch™, UroLift™ and Weck™ – trusted brands united by a common sense of purpose.
At Teleflex, we are empowering the future of healthcare. For more information, please visit teleflex.com.

Position Summary

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.

• 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 elevate Quality issues appropriately to the QA Manager and address other items as assigned by the Manager.

Education / Experience Requirements

• BS Degree in Engineering (or a related technical field)
• 0-2 years of 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.
• 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 REQUIRED: 10 %

The pay range for this position at commencement of employment is expected to be between $72,200- $108,300 ; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position will also include benefits such as medical, prescription drug, dental and vision insurance, flexible spending accounts, participation in 401(k) savings plan, and various paid time off benefits, such as PTO, short- and long-term disability and parental leave, dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.
If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

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At Teleflex, we follow a comprehensive hiring process. We do not accept unsolicited resumes from agency recruiters or 3rd party firms. We do not make unsolicited job offers. We do not ask for money or require equipment purchase up-front.

Teleflex Incorporated is an equal opportunity employer. Applicants will be considered without regard to age, race, religion, color, national origin, ancestry, sexual orientation, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: 877-880-8588 or [e-mail].