Quality Engineering Analyst (SR-2026)

Techlink Systems

Alameda, CA 94502, USA

Published: 6/14/2022

Technology

Full Time

Job Description

Quality Engineering Analyst

Location: Alameda, CA – 100% Onsite
Address: 2601 Harbor Bay Parkway
Contract: 1 Year Contract Position

Job Summary

We are seeking a Quality Engineering Analyst to support complaint tracking, quality data analysis, trending, and investigation activities within a regulated medical device or pharmaceutical environment. The ideal candidate will have experience with complaint handling, CAPA, root cause analysis, quality systems, and regulatory compliance.

Key Responsibilities

Manage and maintain complaint tracking and reporting systems.
Analyze complaint, CAPA, manufacturing, testing, stability, and quality system data to identify trends, risks, and potential quality issues.
Support and conduct root cause investigations for complaints, deviations, and nonconformances.
Determine investigation scope based on risk and quality impact.
Support CAPA activities, including tracking, investigation, and corrective/preventive actions.
Develop reports, dashboards, and data visualizations using Excel and other analytical tools.
Collaborate with Quality, Manufacturing, Operations, Engineering, and R&D teams.
Ensure activities comply with FDA Quality System requirements, ISO standards, and applicable GMP/GxP regulations.
Document investigation findings and support continuous improvement and quality initiatives.

Qualifications

Bachelor's degree in Science, Biomedical Engineering, Mechanical Engineering, or related engineering/scientific discipline.
2–3+ years of experience in medical device, pharmaceutical, biotech, or another FDA/ISO-regulated environment.
Experience with complaint handling, complaint investigation, quality trending, CAPA, and root cause analysis.
Strong analytical and problem-solving skills.
Experience analyzing quality data and identifying trends/risks.
Strong Excel, reporting, and data visualization skills.
Excellent written and verbal communication skills with the ability to work cross-functionally.

Preferred Skills

Experience with TrackWise, eQMS, QMS, or similar quality systems.
Knowledge of FDA 21 CFR Part 820, ISO 13485, GMP/GxP.
Experience with quality dashboards, metrics, and management reporting.
Medical device complaint/MDR experience is highly preferred.

Interview Process

2 interview rounds
1. Video screening with Hiring Manager/Team Lead
2. Panel interview with key stakeholders; a case study may be included to assess investigation/problem-solving approach.

To know more about us visit- https://www.techlinksystems.com/

\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.