Senior Quality Assurance Systems Expert

2 weeks ago


Santa Rosa, California, United States Three Point Solutions Full time
Position Overview

Job Title: Senior Quality Assurance Systems Expert (Remote)

Client: Medical Device Manufacturing Organization

Duration: 1 Year

Shift: Day Shift

Key Qualifications:

  1. Design Control Expertise
  2. ISO 13485 Proficiency
  3. Experience with Class III Medical Devices

Educational Background:

  • Bachelor's Degree
  • Experience Required: A Bachelor's degree with a minimum of 4 years of relevant experience or 2 years with an advanced degree.

Role Summary:

As a Senior Quality Assurance Systems Expert, you will play a crucial role in ensuring adherence to Quality System protocols and Medical Device regulations. You will be involved in initiatives focused on minimally invasive techniques aimed at restoring the structural integrity and functionality of the heart and aorta.

About the Unit:

This unit specializes in minimally invasive solutions for the replacement or repair of heart valves and the placement of stent grafts for treating aortic aneurysms and dissections.

Key Responsibilities:

  • Conduct thorough evaluations of the quality system to guarantee compliance with internal policies, FDA regulations (specifically Design Controls), ISO 13485, and other relevant governmental regulations.
  • Engage in Quality System process initiatives across various locations, contributing to quality system projects.
  • Oversee CAPA management activities, including corrective actions and effectiveness strategies.
  • Lead root cause analyses of Quality System compliance challenges and perform data assessments on findings.
  • Assist in the formulation and execution of Quality System procedures.
  • Undertake additional related tasks as required.

Essential Qualifications:

  • A Bachelor's degree with 4+ years of experience in Quality, Manufacturing, or a regulated industry, or an advanced degree with 2 years of relevant experience.

Preferred Skills:

  • Experience in a regulated setting.
  • Familiarity with audit findings and corrective actions.
  • Background in medical devices, pharmaceuticals, or a similar regulated environment.
  • Strong influence management capabilities; adept at collaborating across various organizational functions and with external stakeholders.
  • Project management expertise.
  • Experience with Quality System documentation tools (e.g., Agile) and Audit documentation systems (e.g., Trackwise).
  • Proficient in reviewing technical documentation.
  • Excellent written and verbal communication skills.
  • Ability to educate others on Quality Systems and Audit processes.
  • Knowledge of quality improvement tools and methodologies.
  • Strong analytical and decision-making abilities.
  • Understanding of FDA regulations (21 CFR 820, 210/211 as applicable), ISO 13485, and specific quality requirements related to CAPA.

About the Client:

At our organization, we strive to revolutionize healthcare globally. We are committed to pushing the boundaries of technology, therapies, and services to alleviate pain, restore health, and enhance life quality. We continuously challenge ourselves to improve, making this a dynamic and fulfilling workplace. Our goal is to accelerate innovation to meet universal healthcare needs and improve patient outcomes.

Physical Job Requirements:

The physical demands outlined in the Responsibilities section are representative of those that must be met by an employee to successfully perform the essential functions of this role. Reasonable accommodations may be made for individuals with disabilities.

Travel Requirements:

  • Occasional domestic and international travel may be necessary.


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