- Perform inspections of purchased parts, subassemblies or finished company products according to well defined criteria using standard physical, mechanical and/ or electrical measurements.
- Rework or reject subassemblies or finished products as required.
- Conduct and document process and system audits using written procedures as audit standards.
- Accurately document the results of the inspections and testing.
- Maintain all controlled document files and test records in a timely and accurate manner.
- Coordinate calibration of all test equipment and fixtures.
- Monitor critical equipment and instrumentation to ensure proper operation and calibration.
- Participate in the construction and/or revision of SOPs for the inspection function.
- Assist in the writing and updating inspection procedures, protocol and checklists.
- Evaluate problems and make initial recommendations for possible corrective action to supervise.
- Work with production management and Quality Assurance to provide feedback to assemblers regarding accuracy of assembly procedures.
- Perform review of Device History Records and other documentation for compliance to established procedures and Good Documentation Practices.
- Perform other duties as assigned by supervisor.
- Mechanical aptitude desired
- Working knowledge of measurement instruments.
- High School Diploma or equivalent
- 0-3 years Quality Control experience is preferred
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Quality Control Inspector - Santa Rosa, United States - Endologix
Description
OverviewEndologix LLC is a California-based, global medical device company dedicated to improving patients' lives by providing innovative therapies for the interventional treatment of vascular disease.
We have a therapeutic portfolio designed to treat diseases which currently have clinically relevant unmet needs. Our existing products can treat a wide spectrum of vascular disease through abdominal aortic aneurysms to lower limb peripheral vascular disease. We obtain excellent clinical outcomes through meticulous attention to product design, manufacturing, and training, all backed by industry-leading clinical evidence.
With a robust pipeline of disruptive technology, our vision is to provide physicians with the best device for each patient; because when it comes to ensuring patient well-being, we are never satisfied with the status quo.
Position Summary:
The Quality Control Inspector will perform inspections, checks, tests, and sampling procedures of incoming materials, parts and components used in the manufacture of medical devices, partially assembled or finished medical devices. This position will also perform review of Device History Records for release of finished goods.
Responsibilities
At Endologix, we see diversity as an opportunity for employees to bring their worldview, their experiences and their perspectives to work every day. We work hard to bring life changing products to patients and believe that a culture which is inclusive of our individual backgrounds and passions will help us create ideas that move all of us forward.
As a global business, our ability to understand, embrace and operate in a multicultural world - in the marketplace and workplace - is critical to our success. Many employees across the company work diligently to help us advance in our diversity journey. Employee feedback gathered both formally and informally further strengthens our culture of inclusion and collaboration as well as initiatives focused on gender and U.S. ethnicities.
Join us, and bring your point of view, talents and contributions so we can all grow together.
