Job Description

We're Hiring: Quality Engineer | Medical Devices | Hybrid/San Jose Area

An innovative medical device company is seeking a Quality Engineer to support and enhance quality systems, compliance, and product integrity. This is an excellent opportunity to make a tangible impact on cutting-edge technologies improving patient care.

Position Summary

In this role, you will use your multidisciplinary engineering background to design, monitor, and support quality initiatives. You will ensure compliance with global regulations, lead investigations, contribute to risk management, and support both design and production activities.

Key Responsibilities

• Support quality operations and ensure ongoing compliance with applicable regulations and standards (ISO 13485, 21 CFR Part 820, etc.).
• Implement and maintain quality system processes, including complaint handling, CAPA, audits, supplier qualification, and equipment control.
• Contribute to product and process monitoring, data analysis, and validation activities.
• Lead or support investigations and root cause analysis for non-conformances.
• Develop and maintain quality documentation, inspection protocols, and control plans.
• Participate in FMEAs (design and process), risk assessments, and quality planning.
• Provide cross-functional support across engineering, manufacturing, and regulatory teams.
• Maintain records to demonstrate product and process compliance.
• Support product development, testing, and post-market surveillance as needed.

Qualifications

• Bachelor’s degree in engineering or a related discipline.
• Minimum of 4 years of experience in a quality engineering role within the medical device or related regulated industry.
• Strong working knowledge of ISO 13485, 21 CFR Part 820, MDD/MDR, and related quality system requirements.
• Proficiency in using statistical tools, CAD software (e.g., SolidWorks), and Microsoft Office applications.
• Ability to perform detailed analysis and work both independently and in a collaborative team environment.
• Familiarity with complaint handling, vigilance, and global regulatory reporting requirements is a plus.

Other Requirements

• Ability to lift and move up to 50 pounds as needed.
• Must be able to work for extended periods under a microscope.
• Willingness to travel up to 25%.

This candidate will be responsible for the development, implementation, maintenance, and improvement of quality assurance processes. Throughout the implementation and maintenance process, this candidate should use data analysis to better understand quality reporting measures and improve processes.

Responsibilities

• Perform problem identification, resolution, loss reporting and continuous improvement
• Design and implement methods for process control, process improvement, testing and inspection
• Develop, execute, and analyze quality reporting measures
• Participate in internal and external quality audits

Qualifications

• Bachelor's degree or equivalent in Mechanical, Electrical, or Manufacturing Engineering
• 4+ years' of industry experience
• Strong knowledge of quality tools used in the industry
• Analytical and quantitative approach to problem solving

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