Quality Assurance Specialist
1 day ago
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 healthcare costs.
We are preparing to grow our team, and it's a great time to join Endotronix.
Job Summary: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.
Responsibilities:
- Inspect and test 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
We are looking for a highly motivated and detail-oriented individual with 1-2 years of QA/QC experience in a manufacturing/production environment. Micro-Vu, Keyence, or Zeta experience is preferred.
The ideal candidate will have:
- Use of Calipers, Micrometers, Microscopes, height gauges, gauge blocks, Optical Inspection/Measurement equipment
- Use of 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
High School Diploma or GED required
About Us: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.
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.
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