Sr. Quality Engineer

Stark Pharma Solutions Inc; Orange (CA); On-site; USD 110,000 - 160,000; Full time

Job summary

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

You will perform DQ/IQ/OQ/PQ/TMV validation, support NCR/CAPA investigations, data analysis, and ensure data integrity while collaborating with Quality, Manufacturing, Project Engineering, and Validation teams.

Qualifications

• Bachelor's degree in Engineering or related field.
• 3+ to 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.
• 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

Documentation

Communication

Analytical skills

Data analysis

Root cause analysis

Problem-solving

SDLC knowledge

Education

Bachelor's degree in Engineering

Tools

CSV

Job description

About the Company

Stark Pharma Solutions Inc. is a global consulting and staffing partner established in 2014, serving the Pharmaceutical, Medical Device, Biotech, and IT industries across the USA, Canada, and India. We provide specialized consulting and staffing solutions across Quality & Validation, Regulatory Affairs, R&D, Manufacturing, Supply Chain, Project Management, and IT, with a focus on delivering tailored solutions that drive growth, operational excellence, and long-term client success.

Position: Sr. Quality Engineer
Location: California
Duration: Long Term

Job Overview

We are seeking a Sr. Quality Engineer with experience in medical device quality engineering, process validation, and risk management to support manufacturing and quality operations.

Key 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.

Required 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.

Stark Pharma is an Equal Opportunity Employer and welcomes qualified candidates from diverse backgrounds.