Quality Engineering Manager

This range is provided by BioTalent. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$165,000.00 / yr - $210,000.00 / yr

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Quality Engineering Manager – Catheter Products

Onsite Role - 5 Days a week

Location : SF Bay Area - East Bay

Compensation : $165,000 – $210,000

Type : On-site

Overview

We are seeking a Quality Engineering Manager to lead a team of 3–5 engineers supporting catheter product manufacturing. This role drives the development, implementation, and continuous improvement of quality engineering functions while ensuring compliance with FDA QSR, ISO standards, and global regulations.

Key Responsibilities

• Manage quality engineering, supplier management, calibration, environmental monitoring, and inspection functions
• Lead and mentor engineers supporting development, inspection, and manufacturing activities
• Ensure compliance with QMS, FDA QSR, ISO, and international requirements
• Support audits and inspections by regulatory agencies and notified bodies
• Drive process validation, test method development, statistical analysis, and improvement projects
• Collaborate on CAPAs, non-conformances, and risk management activities

Qualifications

Working Conditions

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