Quality Inspector II

Job Description

Job 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.

With our recent PMA approval from the FDA, we are preparing to grow our team it’s a great time to join Endotronix!

WHAT YOU’LL DO

As a member of the Quality team, Quality Inspectors 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 ISO13485

• Working in Cleanroom and ESD protected areas according to applicable procedures
• Inspection and testing of incoming medical devices, materials, and mechanical and electrical components
• Collection and evaluation of quality documentation for incoming receipts
• In-process inspection and test of subassemblies
• Final Inspection of completed implantable and other medical devices
• 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
• Execution of 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 of 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
• Quality Control / Inspection participant before, during, and after inspections and audits.

WHAT YOU BRING TO THE TABLE

• 1-2 years QA / QC experience in a manufacturing / production environment
• Micro-Vu, Keyence or Zeta experience preferred
• 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 required

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

• 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

LIFE AT ENDOTRONIX

Endotronix. is an equal opportunity employer. We are committed to providing equal employment opportunities to all persons without regard to race, creed, color, religion, national origin, sex, marital status, citizenship status, age, veteran status or disability.

Furthermore, we do not tolerate any form of discrimination or harassment of our employees by co-workers, supervisors, customers, or vendors.

This commitment extends to our policies on recruiting, advertising, hiring, placement, promotion, training, transfer, wages, benefits, termination and all other privileges, terms and conditions of employment.

This policy applies not only to recruitment and hiring practices, but also includes affirmative action in the area of placement, promotion, transfer, rate of pay and termination.

Executive, management and supervisory levels have the responsibility to further the implementation of this policy and ensure conformance by subordinates