Quality Engineer - Medical Device Manufacturer

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Job details

Looking for Quality Engineer to join our growing company!

This Jobot Job is hosted by Chris Ochoa

Are you a fit? Easy Apply now by clicking the "Apply" button and sending us your resume.

Salary $90,000 - $125,000 per year

A Bit About Us

We are a leading medical device manufacturing company dedicated to developing innovative solutions that improve patient outcomes and enhance healthcare providers' abilities to deliver exceptional care. With years of experience in the industry, we pride ourselves on our commitment to quality and safety in every product we create. Our state-of-the-art facilities and team of highly skilled professionals allow us to stay at the forefront of technological advancements, enabling us to create products that are both effective and reliable. We strive to make a positive impact on the healthcare industry by providing medical devices that are accessible, affordable, and of the highest quality. We are currently looking for a Quality Engineer to join our growing team!

Why join us?

• Great culture
• Opportunity for growth
• Great Benefits
• Strong Compensation

Job Details

Duties and Responsibilities

• Assure Quality System Processes are in compliance with US-FDA, MDD/MDR, ISO 13485 and other applicable country specific medical device

regulations.

• Facilitate receiving inspection and first article inspection activities. Help establish receiving inspection requirements for materials and any needed
• Conduct internal quality audits to ensure compliance to Quality System and regulatory requirements.
• Develop Quality Plans for implementation of new processes or improvements to existing processes

inspection/testing procedures.

• Facilitate material review board meetings. Establish and maintain non-conforming material system.
• Maintain corrective/preventive action system. Work with responsible engineering personnel to perform root cause analysis, develop and implement
• Daily line support activities in manufacturing.
• Facilitate calibration activities. Help establish calibration requirements for measuring equipment and test fixtures as needed.
• Control of suppliers including supplier approval, supplier audits, supplier monitoring and supplier corrective action.
• Support manufacturing in process validation activities.

action plans, and follow-up on implementation and effectiveness of actions taken.

• ASQ Certifications such as Manager of Quality/Organizational Excellence, Quality Engineer, Quality Auditor, Supplier Quality Professional, etc.
• Collection and trending of key quality indicators for management review.
• Certified ISO 13458 / MDD lead auditor.

Interested in hearing more? Easy Apply now by clicking the "Apply" button.

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Click our Jobot logo and follow our LinkedIn page!