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Posted August 20, 2026

Quality Engineering Analyst (Tracking & Trending)Complaints/CAPA

KYYBA
Alameda, CA, US Full Time
45USD - 55USD per hour

Job Description

Job Description

Quality Engineering Analyst (Tracking & Trending)Complaints/CAPA

47687 45-55.00 an hour depending upon exp + 5 PTO days 09/28/2026 to 08/31/2027

Position Overview

Our client is seeking a Quality Engineering Analyst (Tracking & Trending) to support complaint and quality data analysis activities within a regulated medical device environment. This role is responsible for performing trending investigations, analyzing complaint data, identifying potential product and process issues, supporting root cause investigations, and driving continuous improvement initiatives. The individual will collaborate closely with Quality, Operations, Manufacturing, and R&D teams while ensuring compliance with FDA and ISO quality system requirements.

Experience Required

  • 2 to 3 years of experience in a:
    • Medical device industry (preferred)
    • Pharmaceutical industry
    • FDA and/or ISO regulated environment

Required Education

  • Bachelor's Degree in:
    • Biomedical Engineering, or
    • Related Engineering Discipline

Preferred Certifications

  • ASQ Certified Quality Engineer (CQE) or equivalent certification preferred

Required Technical Skills

Candidates should possess experience in the following areas:

  • Quality data analysis and trending investigations
  • Complaint handling and complaint trend analysis
  • CAPA support and root cause investigation methodologies
  • Quality systems within FDA-regulated environments
  • Data analysis and reporting using Excel and related analytics tools
  • Cross-functional collaboration with Quality, Operations, Manufacturing, and R&D teams

Preferred Qualifications

Strong preference for candidates with experience in:

  • JMP
  • Advanced Microsoft Excel
  • SQL querying and data analysis
  • Power BI
  • Basic to intermediate Python programming
  • Quality and complaint management databases
  • Dashboard development and data visualization

Key Responsibilities

  • Perform complaint tracking and trending activities using quality databases and analytical tools.
  • Analyze complaint, CAPA, and quality system data to identify trends, risks, and emerging issues.
  • Support root cause investigations and CAPA activities.
  • Create dashboards, reports, and data visualizations utilizing Excel, Power BI, JMP, SQL, and Python.
  • Partner with Quality, Operations, Manufacturing, and R&D teams to investigate product and process concerns.
  • Document investigative findings and support regulatory compliance requirements.
  • Assist with continuous improvement initiatives related to complaint handling and quality trending processes.
  • Present findings, recommendations, and data-driven insights to stakeholders.

Ideal Candidate Profile

The ideal candidate will have:

  • Experience working in a medical device or other highly regulated environment.
  • Strong analytical and problem-solving capabilities.
  • Experience analyzing complaint and quality data.
  • Exposure to CAPA processes and root cause investigations.
  • Ability to communicate technical findings clearly to cross-functional stakeholders.
  • Proficiency with data analytics and reporting tools.
\nCompany Description

Founded in 1998 and headquartered in Farmington Hills, MI, Kyyba has a global presence delivering high-quality resources and top-notch recruiting services, enabling businesses to effectively respond to organizational changes and technological advances.

At Kyyba, the overall well-being of our employees and their families is important to us. We are proud of our work culture which embodies our core values; incorporating value, passion, excellence, empowerment, and happiness, creates a vibrant and productive atmosphere. We empower our employees with the resources, incentives, and flexibility that they need to support a healthy, balanced, and fulfilling career by providing many valuable benefits and a balanced compensation structure combined with career development.

Kyyba is an Equal Opportunity Employer.

Kyyba does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other b

Company Description

Founded in 1998 and headquartered in Farmington Hills, MI, Kyyba has a global presence delivering high-quality resources and top-notch recruiting services, enabling businesses to effectively respond to organizational changes and technological advances.\r\n\r\nAt Kyyba, the overall well-being of our employees and their families is important to us. We are proud of our work culture which embodies our core values; incorporating value, passion, excellence, empowerment, and happiness, creates a vibrant and productive atmosphere. We empower our employees with the resources, incentives, and flexibility that they need to support a healthy, balanced, and fulfilling career by providing many valuable benefits and a balanced compensation structure combined with career development.\r\n\r\nKyyba is an Equal Opportunity Employer.\r\n\r\nKyyba does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other b

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