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Quality Engineer, Senior Staff - Hyderabad

Confluent Medical Technologies India Pvt Ltd is a 100% owned subsidiary of Confluent Medical Technologies Inc. (HQ in Scottsdale, Arizona -
https://confluentmedical.com/ )
We are dedicated to working collaboratively with our customers, taking their projects from rapid prototype into high volume production. Our unparalleled technical expertise, proven experience and partnership with our clients has allowed us to perfect the process necessary to deliver world-class medical devices through innovative material science, engineering, and manufacturing. Our primary capabilities include: Nitinol components, tubing and wire, balloon expandable stents and balloon catheters, delivery systems, biomedical textiles, access kits, and guidewires.

Confluent Medical is urgently looking for an Senior Staff Quality Engineer to join our team. You may be who we are looking for!

As a uniquely qualified candidate, you will:
Support the manufacturing of Nitinol materials. Work on problems and projects of moderate to complex scope where analysis of situation or data requires a review of identifiable factors, knowledge of industry regulations and best practices, and critical thinking skills. Participate in decisions on scope of work, selection of materials/equipment/test methodology and length of tasks.


Essential Duties and Responsibilities include the following. Other duties may be assigned.

• Support Quality Control inspection for continuous improvement, resolve inspection issues, customer documentation and certification corrections from customer complaints. Qualify and implement document changes involving product or process changes.
• Support manufacturing and process Non-conformance (NCR) & coordinate root cause analysis, reporting of Non-Conforming Products.
• Review Customer Complaints files and coordinate complaint investigation assignment and follow up on progress.
• Implements methods and/or procedures for inspecting, testing and evaluating the precision and accuracy of products and/or production equipment.
• Diagnose and resolve manufacturing and quality system issues.
• Participate in performing design reviews and pre-validation assessments to ensure the safe and environmentally sound start-up of new processes.
• Provide guidance and generate reports for topics involving statistical analysis, including sample size requirements, process capability analysis, regression analysis, tolerance Interval Analysis, ANOVA.
• Support Process Development Engineering in Optimization activities by guiding Design of Experiments of various process parameters and analyzing data.
• Write Process Validation Protocols, Analyze data, write and release Process Validation Reports.
• Communicate with Customer as needed on issues arises from product quality.
• Support Hosting of External Customer and or Notified Body Audits as applicable.
• Investigate and manage customer field complaints, SCAR\xe2\x80\x99s and internal CAPA\xe2\x80\x99s as needed.
• Represent Quality Assurance for Non-Conformance Report dispositions, and own monthly Oversight Review Boards.
• Provide training on quality system procedures and industry regulations/best practices.
• Interface with customers and suppliers as needed for quality issues and project requirements.
• Follows all safety and production standard operating procedures.

Education and/or Experience:

• BS in a related engineering discipline; and 9 years of related experience working in Quality in a medical device environment or equivalent combination of education and experience
• 5+ years experience with FDA, ISO 13485 and EU MDR Design Control requirements
• Creation, execution, and analysis of Measurement System Analysis
• Creation and execution of equipment qualifications.
• Strong statistical data analysis skills using Minitab
• Competent in Microsoft Office applications

Confluent Medical Technologies offers very competitive compensation and benefits and is proud to have a distinguished reputation throughout the medical device industry around the world! We welcome eager and ambitious team players to apply!

Confluent Medical Technologies is an equal opportunity employer