Manufacturing Quality Engineer
Job in
Hayward, Alameda County, California, 94557, USA
Listed on 2026-10-16
Listing for:
Sibitalent Corp
Full Time
position Listed on 2026-10-16
Job specializations:
-
Engineering
Quality Engineering, Biomedical Engineer, Process Engineer -
Quality Assurance - QA/QC
Quality Engineering
Job Description & How to Apply Below
- 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
.
- 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.
- 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
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.
- 1. Medical device Quality Engineering
- 2. Process Validation
- 5. CSV/Software Validation + Data Integrity
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