Quality Engineering Analyst

Job Title: (Quality Engineering Analyst)
 
About Kyyba:
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. 
 
Job Description

This position is NonExempt. Hours over 40 will be paid at Time and a Half. BA in Sciences. The incumbent will design and maintain a complaint tracking and reporting system; evaluate medical and non-medical complaints and stability investigation requests and make technical judgment on the nature of the problem; evaluate shipping, manufacturing, equipment, validation, engineering project, testing/inspection results, product specifications, employee training records as well as Basic Operating Procedures, SPC/quality trend data, and or stability reports, as applicable, to determine the root causes of the problem. The reviewer expert it own judgment based on experience to determine the depth of the investigation required associated the level of risk of non-conformance. Maintain a tracking and follow up-system to ensure compliance of Quality Engineering with the FDA Quality Systems Inspection Techniques.
Quality Engineering Analyst (Tracking & Trending)
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.
Interview Process
Two-Step Interview Process
Initial Video Interview with Hiring Manager and/or Team Lead
Panel Interview with Key Stakeholders
 
Location: (Alameda,CA)
 
Disclaimer: 
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 basis covered by appropriate law. Minorities / Females / Protected Veterans / Individuals with Disabilities are encouraged to apply. All employment is decided on the basis of qualifications, merit, and business need.”
It is the policy of Kyyba to provide reasonable accommodation when requested by a qualified applicant or employee with a disability, unless such accommodation would cause an undue hardship. The policy regarding requests for reasonable accommodation applies to all aspects of employment, including the application process. If reasonable accommodation is needed, please contact Kyyba at 248-813-9665
 
Rewards:
Medical, dental, vision
401k 
Term life
Voluntary life and disability insurance
Optional Pre-paid legal plan
Optional Identity theft plan
Optional Medical and dependent FSA
Work-visa sponsorship
Opportunity for advancement
Long-term assignment with opportunity for hire by client 
 
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• An INC 5000 company for 10 years
• Corp! Michigan Economic Bright Spots 
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• TechServe Alliance Excellence Award- IT and Engineering Staffing & Solutions
• Best of MichBusiness winner in HR Wizards & Partnerships
• Metro Detroit Elite Category: Recruitment, Selection & Orientation for 101 Best & Brightest
• 101 Best & Brightest Companies to Work for in Michigan