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Quality Technician I
Endotronix
Quality Assurance
Naperville, IL, USA
Posted on Sep 20, 2024
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, the Quality Technician 1 will support the development of inspection equipment and test methodologies to ensure that the product, processes and procedures meet a predefined standard of quality. Responsibilities include supporting the troubleshooting and maintenance of all equipment calibration, down-time, etc.
The technician will complete routine inspection and testing of materials, components, subassemblies, and final assemblies of implants, delivery catheters, and electronic medical equipment.
This position supports process controls, material controls and non-conformance controls, including investigations, to comply with Quality System, 21CFR820, 21CFR11 and ISO 13485
- Working in Cleanroom and ESD protected areas according to applicable procedures
- Support test method development and equipment identification/functionality to optimize process efficiency, repeatability and ergonomic attributes.
- 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 logs and databases
- Contribute to and maintain Device History Records, including in electronic systems and on paper
- Support the development and update of inspection procedures, programs, forms and checklists
- Ensure metrology equipment is maintained and calibrated as required
- Support the development of Test Methods and 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 during FDA inspections and internal and external audits.
- Develop and maintain inspection reports
- Ensure compliance to applicable regulatory requirements as well as company standards and specifications
- Prepare and maintain test data for review
- Identify areas for quality control improvement and implement new methods accordingly
- Communicate quality or compliance concerns with urgency
- Perform routine analysis on processes and products. Guarantees finished products meet required specifications prior to releasing shipments
- Enters data into databases and communicates results verbally or in writing as required. Resolves problems by examining and evaluating data; select corrective steps
- Supports feasibility/testing and experiments under the direction of more senior team members
- Performs inspection coaching and/or mentoring to facility employees
- Handle complex clerical, administrative or technical issues under supervision and escalating the most complex issues to the appropriate staff
WHAT YOU BRING TO THE TABLE
- Understanding of test equipment
- Minimum of 1 year of experience as a Technician
- Knowledge of various mathematical concepts including fractions, ratios, and proportions
- Demonstrated ability to work independently with supervision
- Excellent organizational skills
- Demonstrated ability to analyze and interpret information
- Possesses working knowledge of inspection and measurement equipment, including, but not limited to: Calipers, Micrometers, Microscopes, height gauges, gauge blocks, tensile tester, Optical Profilometer, Vision Measurement Systems
- 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 values
- Demonstrated ability to work independently with ability to interact with others, as needed
- Excellent attention to detail
- Solid oral and written communication skills including legible handwriting and printing for written records
- Read and interpret mechanical drawings
- Mechanical aptitude
- IPC–A-610 certification preferred
EDUCATION
- High School Diploma or GED required
- Active Professional certification required (e.g. Institute for Printed Circuits (IPC), Certified Quality Technician (CQT), Certified Quality Inspector (CQI))
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 his/her track record of outstanding performance.
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
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6701 Carnegie Ave. Suite 100
Cleveland, Ohio 44103
Tel: 216.363.3400
Email: [email protected]
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