Senior Quality Engineer – Med Device, Process Validation

Stark Pharma Solutions Inc; Orange (CA); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Equal Opportunity Employer

Job summary

Stark Pharma Solutions Inc. is seeking a Sr. Quality Engineer with expertise in medical device quality engineering, process validation, and risk management to support manufacturing and quality operations.

The candidate will perform DQ/IQ/OQ/PQ/TMV, support NCR/CAPA, data integrity, CSV, and software validation activities. Collaboration with Quality, Manufacturing Engineering, Project Engineering, and Validation teams is essential for continuous improvement in a regulated environment.

Qualifications

• Bachelor's degree in Engineering or related field.
• 3-5+ years of Quality Engineering experience.
• Medical device industry experience.
• Experience with process validation and risk management.
• Experience with DQ, IQ, OQ, PQ, and TMV.
• Experience with NCR, CAPA, root cause analysis, and problem-solving.
• Knowledge of Computer System Validation (CSV).
• Knowledge of data integrity and SDLC is preferred.
• Strong documentation, communication, and analytical skills.
• Lean or Six Sigma certification is a plus.

Responsibilities

• Support Quality Engineering activities for medical device manufacturing.
• Perform process validation activities including DQ, IQ, OQ, PQ, and TMV.
• Support risk management activities and documentation.
• Perform root cause investigations and support NCR/CAPA activities.
• Analyze quality and manufacturing data to identify trends and improvements.
• Support Computer System Validation (CSV) and software validation activities.
• Support data integrity and software change control assessments.
• Work with Quality, Manufacturing Engineering, Project Engineering, and Validation teams.
• Update procedures and quality documentation.
• Support continuous improvement and maintain processes in a state of control.

Skills

Quality engineering

Process validation

Risk management

CSV

Education

Bachelor's degree in Engineering

Job description

Stark Pharma Solutions Inc. is seeking a Sr. Quality Engineer with expertise in medical device quality engineering, process validation, and risk management to support manufacturing and quality operations.

The candidate will perform DQ/IQ/OQ/PQ/TMV, support NCR/CAPA, data integrity, CSV, and software validation activities. Collaboration with Quality, Manufacturing Engineering, Project Engineering, and Validation teams is essential for continuous improvement in a regulated environment.