Quality Engineer III

Conmed Corporation Largo , FL 33779

Posted 2 months ago

The Quality Engineer III collaborates cross-functionally to support the production factories, lines and cells during the manufacturing process of CONMED medical devices. The Quality Engineer III supports operations with the objective of maintaining high quality standards for the product manufacturing process and the conformance to the CONMED Quality Management System and the regulatory requirements. If you are ready to have an immediate impact at CONMED, apply today!

Duties and Responsibilities:

1.Understand and follow all CONMED policies; follow standards for safe behaviors; deploy the CONMED Pillars while executing the QE role at CONMED.

2.Develop, Implement, and maintain quality system processes and procedures to ensure compliance to all domestic and international standards or requirements. (EN ISO 13485/CMDCAS/MDD & FDA QSR).

3.Keep current on all applicable best practices and statutory regulations governing the design, procurement, manufacture, marketing, and distribution of medical devices.

4.Demonstrate leadership and initiative to plan and perform engineering assignments that support company goals and objectives.

5.Apply Quality Engineering tools such as Failure Mode & Effects Analysis (FMEA), Fault Tree Analysis (FTE), Root Cause Analysis, Design of Experiment (DOE) etc., to the development of new products or processes; and in solving process/product-related problems. Promote and apply the DMAIC/PDCA Methodology for product/process/system improvements.

6.Direct and guide the Quality Technicians in the factory.

7.Provide support to Operations on quality assurance/control issues including but not limited to:

  • Day-to-day troubleshooting situations

  • Communication/escalation of key quality issues

  • NCR/NCP management, complaint management, CAPA management

  • Change management

  • Risk Management

  • Quality Objectives management through data analysis that supports the CONMED Operating System/Tier process and drives a continuous improvement culture

  • Statistical Analysis

  • Training/consultation on quality concepts, quality technology tools, and investigation techniques

8.Support new product introductions through the design transfer activities including but not limited to:

  • Collaborate with manufacturing engineering to develop a strategy for process assurance activities related to new product launch - review/approve process assurance documents (IQs, OQs, PQs, VEs, Test Method Validations)
  • Review/approve change notices associated with the introduction of process documentation related to new product launch (tooling drawings, work instructions, process travelers, control plans and inspection procedures)
  • Collaborate with manufacturing engineering/R&D to develop process risk documents (PFMEAs)
  • Review/approve Design Transfer Matrix (DTM) to ensure all critical product characteristics have been addressed prior to product launch

9.Direct the resolution of quality issues by fostering cross-functional partnerships through effective communication, engagement activities, and influencing behaviors

Qualifications:

  • 5 years experience in the medical device or related industry; thorough understanding of 21CFR820/ISO13485/ISO14971

  • Bachelor's Engineering degree or related technical, science-based degree

  • Knowledge of quality principles, systems, methods, problem-solving tools, and statistical principles; CQE, black belt, lean six sigma certification preferred

  • Excellent communication, relationship building, influencing, leadership, problem-solving, critical thinking, planning and time management skills required

  • This position is not open to employer based sponsorship.

  • Travel 0-20%

Benefits:

CONMED offers

  • Competitive compensation

  • Excellent healthcare including medical, dental, vision and prescription coverage

  • Short & long term disability plus life insurance -- cost paid fully by CONMED

  • Retirement Savings Plan (401K) -- company match dollar for dollar up to 7% Employee stock purchase plan -- allows stock purchases at discounted price

  • Tuition assistance for undergraduate and graduate level courses

CONMED is an Equal Opportunity Employer & an Affirmative Action Employer. CONMED is a strong advocate of workforce diversity. All qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

If you feel you need a reasonable accommodation pursuant to the ADA, you are encouraged to contact us at 800-325-5900 option #3.

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Quality Engineer III

Conmed Corporation