Quality Analyst/Quality Engineer (Onsite) - MM25

Published: 6/14/2022

Technology

Job Description

Job Title: Quality Engineering Analyst
Locatio: Alameda, CA, (onsite)
Contract Duration: Contract until 08/31/2027
Working hours: 8 am - 5 pm
Total hours: 40

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

\nCompany Description

We serve the contract staffing, direct hire, staff augmentation, recruitment, HR management, and project outsourcing needs of clients nationwide. Striving to create personal relationships with clients, TechLink Systems becomes a virtual extension of clients’ own in-house capabilities to help achieve new levels of growth, productivity, and competitiveness.

Company Description

TechLink Systems is a national provider of staffing services with offices all over the USA as well as development and support centers globally. We are a MBE (NMSDC), WBE (WBENC), and WOSB certified minority business that has been awarded 2017 TAPFIN Premier Partner, 2016 Manpower Excellence Award, 2016 TAPFIN Elite Partner, are a Known Tier Supplier for Agile 1, and have been ranked as a Top Women and Minority Owned Company since 2004 by several businesses including Philadelphia Business Journal, Diversity Business, Inc 5000, Inc 500, San Francisco Business Times, Diversity2000, and Los Angeles Business Journal. \r\n\r\nWe serve the contract staffing, direct hire, staff augmentation, recruitment, HR management, and project outsourcing needs of clients nationwide. Striving to create personal relationships with clients, TechLink Systems becomes a virtual extension of clients’ own in-house capabilities to help achieve new levels of growth, productivity, and competitiveness.