Job ID

2024-2967

Location

US-CA-Santa Rosa

Category

Quality

Endologix 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

Provides support in the development and maintenance of company’s Quality Systems. Plans and implements Quality Assurance programs designed to ensure continuous production of products consistent with established standards by performing the following duties:

• Establishes and maintains Quality Assurance programs, procedures, and controls. Ensures that performance and quality of products conform to established company and regulatory standards.
• Supports Quality Control activities (Production, Receiving Inspection, Finished Goods, and Calibration). Helps to meet established schedules or resolve technical or operational problems. Assist in supervisory activities of Quality Control personnel.
• Perform non-conformance investigations to determine root case. Assign and ensure completion of corrective and preventive actions. Complete investigations in a timely manner to ensure customer service levels are maintained. Coordinate the reporting and provide trend analysis for non-conformance incidences.
• Determines equipment qualification, process validation, and product line design/modifications requirements. Advises Manufacturing on installation and maintenance of inspection and testing procedures for raw materials, packaging materials, components and finished products. Supports design transfer activities.
• Works with Manufacturing to provide feedback to production personnel regarding accuracy of assembly procedures. Works with Facilities to establish and maintain effective environmental monitoring systems.
• Leads development of Risk Management documentation.
• Assists in conducting and documenting process and system audits using specific regulations and company procedures as audit standards.
• Promotes and organizes training activities related to product quality, cost, reliability, and regulatory compliance. Develops strategies to ensure continuous improvement in the ability to design and manufacturing quality products.
• Maintains an up‑to‑date knowledge in the techniques of Quality Assurance/Quality Control and in the company products and process technologies.
• Perform other duties as assigned by supervisor

• Strong communication and organization skills required
• Good judgment skills within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
• Flexibility to handle multiple tasks and meet timelines. Normally receives minimal instructions on routine work, general instructions on new assignments.

Education:

• Bachelor’s degree in a scientific discipline or equivalent

Experience:

• Minimum of 5 years experience in an FDA regulated industry.
• Experience with problems of diverse scope in which analysis of data requires evaluation of identifiable factors.

Salary Range:

$82,000.00- $130,000.00

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.

Endologix, Inc. is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.

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