Manufacturing Quality Engineer

IMMEDIATE INTERVIEW = Quality Engineer (medical devices) in Hayward CA- Onsite

Job Title: Quality Engineer (medical devices)

Contract: 12+ month contract

Location: Onsite Hayward CA

Lean or Six Sigma Green Belt or higher is preferred.

Job Description

Quality Engineer – Hayward Facility

Industry: Medical Device / Healthcare Manufacturing

Must-Haves

• Bachelor’s degree in Engineering or related field.
• 3–5+ years of Quality Engineering experience , preferably in medical devices.
• Hands-on experience with process validation and risk management .
• Strong understanding of manufacturing processes, product/process interactions and quality controls.
• Experience with root cause analysis, NCR/CAPA and continuous improvement .
• Strong technical documentation and communication skills.
• Ability to work in a regulated medical device/GxP environment .

Preferred

• Lean/Six Sigma Green Belt or higher .
• Experience with CSV/software validation, SDLC, data integrity and cybersecurity .
• Master’s degree in Engineering or Business Administration.

Relevant Job Titles

• Quality Engineer
• Senior Quality Engineer
• Quality Systems Engineer
• Manufacturing Quality Engineer
• Process Quality Engineer
• Validation Engineer
• Quality/Validation Engineer
• Medical Device Quality Engineer
• CSV/Validation Engineer

Key Keywords

Medical Device | Process Validation | Risk Management | CAPA | NCR | Root Cause Analysis | DQ/IQ/OQ/PQ | TMV | CSV | Software Validation | GxP | Data Integrity | SDLC | Cybersecurity | cGDP | Lean Six Sigma

Must-Haves – Quality Engineer

• Bachelor’s degree in Engineering or related field.
• 3–5+ years of Quality Engineering experience, in medical device manufacturing.
• Hands-on experience with process validation and validation protocols such as DQ, IQ, OQ, PQ, TMV.
• Strong experience with Risk Management for medical devices.
• Experience with NCR/CAPA and root cause investigations.
• Knowledge of GxP/cGDP, regulatory compliance, and quality systems.
• Experience analyzing process/product data, trends, specifications, and quality performance.
• Experience with Computer System Validation (CSV)/software validation is important.
• Understanding of data integrity, SDLC, software change control, and cybersecurity impact assessments.
• Strong documentation, communication, and problem-solving skills.
• Ability to work closely with Manufacturing Engineering and Project Engineering on process improvements and product transitions.

Top 5 screening points:

1. Medical device Quality Engineering

2. Process Validation

3. Risk Management

4. CAPA/NCR + Root Cause Analysis

5. CSV/Software Validation + Data Integrity