Quality Engineer (medical devices)

Quality Engineer (Onsite)

Location: Hayward, CA

Interview:Phone+Skype

Industry: Medical Device / Healthcare Manufacturing

Role Summary:

Quality Engineer responsible for supporting manufacturing quality from raw materials through finished medical devices. The role focuses on process validation, risk management, quality investigations, CAPA/NCR, computer/software validation, data integrity, and continuous improvement while ensuring compliance with regulatory and company requirements.

Key Responsibilities

• Support manufacturing processes and ensure they remain in a state of control and compliance.
• Perform process validation activities including DQ, IQ, OQ, PQ and TMV.
• Develop and maintain Risk Management documentation for product families and software defects.
• Conduct root cause investigations and support NCR/CAPA activities.
• Analyze manufacturing/process data, trends, specifications and product performance.
• Develop inspection criteria and procedures to maintain product quality.
• Perform/support Computer System Validation (CSV) and software validation for GxP systems.
• Assess software changes for validation, data integrity, hardware interaction and cybersecurity impacts.
• Support SDLC, CSV, data integrity and cybersecurity compliance.
• Partner with Manufacturing and Project Engineering during new project/process transitions.
• Identify opportunities for quality and manufacturing process improvements.
• Maintain accurate cGDP-compliant documentation and quality records.

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

Himanshu Goswami

Sr. IT Technical Recruiter

Stellent IT Phone:

Email: Himanshu.goswami
Gtalk: Himanshu.goswamiom