Quality Engineer II

Job Title: Quality Engineer II

Company Overview: Our client is a global healthcare leader dedicated to improving lives through innovative medical technologies. With a presence in over 160 countries, we provide solutions ranging from diagnostics to medical devices, offering transformative products that aid in patient care decision-making across various health conditions. Our Temecula, California location within the AVD Vascular business unit specializes in delivering minimally invasive and cost-effective treatments for vascular disease, including a comprehensive portfolio of medical devices and software solutions.

Job Summary: We are seeking a Quality Engineer II to join our team in Temecula, California. This role plays a pivotal part in ensuring the quality and compliance of our medical devices, working closely with cross-functional teams to maintain adherence to regulatory requirements and industry standards. The successful candidate will leverage their expertise in quality assurance and engineering to drive continuous improvement initiatives and uphold the highest standards of product quality.

Key Responsibilities:

Collaborate with Manufacturing, Information Management, Research Development & Engineering, Quality Assurance Operations, and Product Performance Analysis teams to ensure compliance with LifeScan software development procedures and industry regulations.

Review and approve deliverables throughout the software development lifecycle.

Lead teams in performing Hazard Analysis.

Occasionally assist teams in developing tailored Standard Operating Procedures and Work Instructions for software development activities.

Provide occasional training for select software development activities for LifeScan.

Occasionally write and execute test protocols and reports.

Qualifications:

Bachelor's degree in Engineering required, with a focus on Mechanical Engineering or Biomedical Engineering preferred.

3-5 years of experience in Engineering, preferably within the medical device manufacturing industry.

Strong attention to detail and ability to manage regulatory compliance and reporting requirements.

Experience with Hazard Analysis, software development lifecycle, and standard operating procedures development preferred.

Knowledge of FDA Quality System Regulation, ISO13485, and other international standards.

Excellent communication and interpersonal skills, with the ability to collaborate effectively across teams.

Proven ability to lead and drive quality improvement initiatives in a dynamic environment.

This job will be reviewed periodically and is subject to change by management.

NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.

The Company complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law, including disability/veteran status. This position may require you to work onsite or interact in person with customers of the Company and/or work onsite from time to time at the Company’s facilities.

Link to the Job Description on our company website: