Manufacturing Quality Engineer

Sibitalent Corp; Hayward (CA); On-site; USD 90,000 - 130,000; Full time

Job summary

Sibitalent Corp in Hayward, CA is seeking a Quality Engineer (medical devices) for an onsite 12+ month contract. You will lead quality engineering activities within a regulated GxP environment, focusing on process validation and risk management.

The role requires a Bachelor's degree in Engineering and 3–5+ years in medical device quality, with hands-on experience in NCR/CAPA, root cause analysis, and documentation. Familiarity with CSV/software validation and SDLC is a plus.

Qualifications

• Bachelor's degree in Engineering or related field is required.
• 3–5+ years of Quality Engineering experience in medical devices.
• Hands-on experience with process validation and risk management.
• Strong documentation and communication skills in a regulated environment.
• Familiarity with NCR/CAPA, root cause analysis and continuous improvement.

Skills

Quality Engineering

Process Validation

Risk Management

Root Cause Analysis

Documentation Skills

Education

Bachelor's degree in Engineering

Master's degree in Engineering or MBA

Tools

CSV/Software Validation

Regulatory Compliance Tools

Job description

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

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
• 5. CSV/Software Validation + Data Integrity