Professional - Engineering - Quality Engineer I

Mindlance; Irvine; On-site; GBP 35,000 - 50,000; Full time

Job summary

A medical device company in Irvine is seeking a Quality Engineer responsible for maintaining quality and control of manufacturing processes. The role involves leading investigations, developing plans for quality assurance, and ensuring compliance with FDA regulations and ISO standards. Preferred candidates will have a Bachelor’s degree in Engineering and experience in a regulated environment. This position offers an opportunity to contribute to product performance and quality within a dynamic team.

Qualifications

• 2 years of relevant experience in a regulated industry preferred.
• Knowledgeable of FDA regulations and ISO 13485 standard.

Responsibilities

• Develop and execute plans for quality and control.
• Lead investigations into quality issues to identify root cause.
• Monitor and analyze product performance of medical devices.
• Perform troubleshooting of customer returned devices.
• Develop tools to communicate complex technical problems.
• Ensure compliance with quality system policies.

Skills

Project management

Data analysis

Root cause analysis

Communication

Risk determination

Education

Bachelor’s degree in Engineering

Job description

The Quality Engineer is responsible for maintaining quality and control of manufacturing processes and post‑market performance of medical devices. Responsibilities include collaborating with internal and external stakeholders to achieve company objectives, leading technical root cause investigations, developing and executing risk‑based decisions, resolving and documenting customer complaint and manufacturing investigations, and representing Quality in cross‑functional projects.

Job Duties

• Develops and executes plans for quality and control to ensure manufacturing continuity and product conformance.
• Leads investigations into production and customer‑facing quality issues to identify root cause, implement corrective and preventative actions, and monitor effectiveness.
• Monitors and analyzes product performance of medical devices using a statistical and risk‑based approach. Considers any quality, compliance, customer, and business risks.
• Performs hands‑on troubleshooting of customer returned devices and manufacturing nonconformities and completes associated technical documentation.
• Develops tools to communicate complex technical problems and solutions to a variety of audiences within the organization.
• Proficient in project management, data analysis, root cause analysis, communication, and risk determination.
• Ensure compliance with the company's Quality System policies and procedures and applicable external requirements and standards, including FDA, ISO 13485, and other worldwide regulatory agencies as pertaining to medical devices.

Minimum Requirements

• Bachelor’s degree in Engineering

Preferred Experience

• 2 years of relevant experience in a regulated industry (FDA environment preferred)
• Knowledgeable of FDA regulations, 21 CFR part 820 and Part 803 and ISO 13485 standard

EEO

“Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”