Product Design Quality Engineer

Stark Pharma Solutions Inc; Bothell (WA); On-site; USD 110,000 - 140,000; Full time

Job summary

Stark Pharma Solutions Inc. in Bothell, WA is seeking a Product Design Quality Engineer to drive design quality, validation, and risk management across product development from concept to launch.

The role requires strong experience with IQ/OQ/PQ, CAPA, and post-market surveillance, plus collaboration with Engineering, R&D, Manufacturing and Quality to ensure regulatory compliance.

Qualifications

• 4+ years of experience with a Bachelor's degree in Quality Engineering, Safety Engineering, R&D Engineering, or a related field.
• Experience with Design Quality Management and Design Controls.
• Experience with design verification and design validation.
• Experience with process validation and IQ/OQ/PQ.
• Strong knowledge of risk assessment and risk management.
• Experience with CAPA and root cause analysis.
• Strong data analysis and interpretation skills.
• Experience with technical and quality documentation.
• Knowledge of regulatory and quality requirements.
• Experience with product quality, reliability, and defect management.

Responsibilities

• Support products from concept through commercialization and design transfer.
• Develop and execute process validation strategies.
• Support IQ/OQ/PQ and process capability activities.
• Manage design control activities, including design inputs, reviews, verification, and validation.
• Prepare and maintain quality plans and technical documentation.
• Support hardware, software, and system quality activities.
• Identify and assess product and manufacturing risks.
• Support risk management and risk mitigation activities throughout the product lifecycle.
• Perform root cause analysis and resolve quality issues.
• Manage CAPA activities and verify corrective action effectiveness.
• Review product performance and post-market data to identify quality improvements.
• Support quality audits and regulatory inspections.
• Drive continuous improvement and product quality initiatives.
• Work closely with Engineering, R&D, Manufacturing, Quality, and other cross-functional teams.

Skills

Design Quality Management

Design Controls

CAPA

Risk Management

Root Cause Analysis

Process Validation

Quality Documentation

Data Analysis

Cross-functional Collaboration

Regulatory Knowledge

Education

Bachelor's or Master's degree in Mechanical/Electronics Engineering or Science

Bachelor's degree in Quality Engineering or related field (minimum 4+ years experience)

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

Product Design Quality Engineer

Location

Bothell, WA

Duration

Long Term

Job Overview

We are seeking a Product Design Quality Engineer with experience in design quality, process validation, risk management, CAPA, and product development within a regulated environment.

Key Responsibilities

• Support products from concept through commercialization and design transfer.
• Develop and execute process validation strategies.
• Support IQ/OQ/PQ and process capability activities.
• Manage design control activities, including design inputs, reviews, verification, and validation.
• Prepare and maintain quality plans and technical documentation.
• Support hardware, software, and system quality activities.
• Identify and assess product and manufacturing risks.
• Support risk management and risk mitigation activities throughout the product lifecycle.
• Perform root cause analysis and resolve quality issues.
• Manage CAPA activities and verify corrective action effectiveness.
• Review product performance and post-market data to identify quality improvements.
• Support quality audits and regulatory inspections.
• Drive continuous improvement and product quality initiatives.
• Work closely with Engineering, R&D, Manufacturing, Quality, and other cross-functional teams.

Required Qualifications

• Bachelor's or Master's degree in Mechanical Engineering, Electronics Engineering, Science, or a related field.
• 4+ years of experience with a Bachelor's degree in Quality Engineering, Safety Engineering, R&D Engineering, or a related field.
• Master's degree candidates may be considered with limited or no prior experience.
• Experience with Design Quality Management and Design Controls.
• Experience with design verification and design validation.
• Experience with process validation and IQ/OQ/PQ.
• Strong knowledge of risk assessment and risk management.
• Experience with CAPA and root cause analysis.
• Strong data analysis and interpretation skills.
• Experience with technical and quality documentation.
• Knowledge of regulatory and quality requirements.
• Experience with product quality, reliability, and defect management.
• Strong problem-solving and continuous improvement skills.
• Good communication and cross-functional collaboration skills.

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