Quality Engineer – Medical Device, Design Controls (Onsite)

Stark Pharma Solutions Inc; West Valley City (UT); On-site; USD 85,000 - 125,000; Full time

Job summary

Stark Pharma Solutions Inc. is seeking an experienced Quality Engineer for a 12+ month onsite assignment in West Valley City, UT. The role focuses on design quality, integration, and remediation in a regulated medical device environment.

You will lead design controls activities, support DHF remediation, and drive risk management, V&V, and TRM efforts across the product lifecycle with cross-functional teams.

Qualifications

• Bachelor’s degree in Engineering or related technical field.
• 4+ years of Quality Engineering in medical devices.
• Strong experience with FDA 21 CFR Part 820 requirements.
• Hands-on risk management and V&V activities.
• Experience with design integration and DHF remediation.
• Strong technical writing and cross-functional collaboration.

Responsibilities

• Support NPD and Design Quality activities per FDA 21 CFR Part 820.
• Lead DHF remediation and design integration projects.
• Develop and execute risk management activities and analyses.
• Author and review design control docs, V&V protocols and reports.
• Support DFМ principles and quality improvements.
• Collaborate with R&D, Manufacturing, Regulatory, and Quality teams.
• Participate in remediation and integration initiatives to ensure compliance.
• Support design transfer, change control, and lifecycle management.

Skills

Design Controls

Risk Management

V&V (Verification & Validation)

TRM/TMV (Technical Risk Management)

DFM (Design for Manufacturability)

Education

Bachelor's degree in Engineering

Job description

Stark Pharma Solutions Inc. is seeking an experienced Quality Engineer for a 12+ month onsite assignment in West Valley City, UT. The role focuses on design quality, integration, and remediation in a regulated medical device environment.

You will lead design controls activities, support DHF remediation, and drive risk management, V&V, and TRM efforts across the product lifecycle with cross-functional teams.