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Quality Inspector II

4 months ago

Naperville, United States Endotronix, Inc Full time
Job DescriptionJob Description

WHO ARE WE?


Endotronix is a medical device company that aims to transform the treatment of heart failure, a chronic, progressive condition in which the heart is unable to pump enough blood to support the body. Our Cordella Heart Failure System (CHFS) includes proactive management tools for best practice care and detection of worsening heart failure. These easy-to-use tools improve patient quality of life and help to reduce hospital admissions thereby reducing health care costs.

WHAT YOU’LL DO


As a member of the Quality team, you will inspect and test materials, components, subassemblies, and final assemblies of implants, delivery catheters, and electronic medical equipment. This position also supports process controls, material controls and non-conformance controls to comply with Quality System, 21CFR820, 21CFR11 and IS013485. This is a full-time, onsite position based in Naperville, IL. Your responsibilities will include:

  • Work in the Cleanroom and ESD protected areas according to applicable procedures
  • Inspect and test incoming medical devices, materials, and mechanical and electrical components
  • Collect and evaluate quality documentation for incoming receipts
  • In-process inspection and test of subassemblies
  • Final Inspection of completed implantable and other medical devices
  • Provide documentation and communication of inspection and test results and non-conformances according to approved Quality System procedures and GDP.
  • Support control, investigation, disposition, and documentation of non-conforming material
  • Execute material control procedures including receipt, identification, quarantine, and material movement to/from Quality including use and maintenance of material control, non-conformance, work order and serial number logs and databases
  • Contribute to and maintain Lot and Device History Records
  • Develop and update inspection procedures, programs, forms and checklists
  • Ensure metrology equipment is maintained and calibrated as required
  • Support Process Validation and Test Method Validation executions including IQ/OQ/PQ and gage R&R
  • Maintain knowledge of all procedures, relevant specifications and applicable regulations and standards related to areas of responsibilities
  • Serve as Quality Control/ Inspection participant before, during, and after inspections and audits.

WHAT YOU BRING TO THE TABLE

  • 1+ years QA/QC experience in a manufacturing/production environment
  • Use Calipers, Micrometers, Microscopes, height gauges, gauge blocks, Optical Inspection/Measurement equipment
  • Use Microsoft Office/Google apps including electronic mail, routine database activity, word processing, spreadsheets
  • Ability to handle conflict and deadline pressures professionally with commitment to ethics
  • Demonstrated ability to work independently with ability to interact with others, as needed
  • Excellent attention to detail
  • Strong oral and written communication skills including legible handwriting and printing for written records
  • Strong math skills
  • Read and interpret mechanical drawings
  • Mechanical aptitude

EDUCATION

  • High School Diploma or GED

WHO YOU ARE

  • Relentlessly focused on data and hypothesis driven decision making to create the best experiences for ETX patients and customers
  • Someone with a bias for action and quick iteration as opposed to perfection
  • A quick learner, who is able to work independently, multitask, and drive your own projects
  • An effective communicator and collaborator who can synthesize insights from multiple stakeholders across business functions to deliver purpose-built insights, models and tools that provide easily interpretable and actionable results
  • A team player who can inspire teams to deliver together, embodying the idea that the whole is greater than the sum of the parts
  • Passionate about digital healthcare and leveraging Data to deliver innovative solutions at scale

WHAT WE’RE LIKE

  • Willing to have the “direct and honest conversation”. Not afraid to confront the facts (or be confronted) and develop a plan to move forward.
  • Competitive spirit and drive to win. Strong sense of initiative, internal motivation, and an unrelenting focus on results.
  • Openness to feedback and coaching with a strong orientation towards continual learning and improvement. Ability to solicit, accept and provide direct feedback without defensiveness.
  • Capacity to function in a highly complex company with ease and fluidity, while driving and influencing results.
  • Entrepreneurial, flexible, yet results focused.
  • High degree of intellectual curiosity, honesty, and capability.
  • Low ego and humble in spirit in spite of your track record of outstanding performance.

LIFE AT ENDOTRONIX

  • Our shared company values create a foundation of trust and collaboration. United in a common purpose, we excel at the task at hand to provide best-in-class medical technology and customer service to our patients and clinicians. And along the way we make sure to have a little fun, continue to grow and celebrate our successes.
  • We provide a competitive compensation package, comprehensive benefits including unlimited PTO, and an environment that will help you to thrive and succeed in your career.
  • Endotronix is an equal opportunity employer, and we are committed to providing equal employment opportunities to all persons without regard to race, creed, color, religion, national origin, gender, marital status, citizenship status, age, veteran status, or disability. We are passionately committed to building a diverse organization where all perspectives and cultures are celebrated.