Quality Engineer

Stark Pharma Solutions Inc; West Valley City (UT); Presencial; USD 85.000 - 125.000; Jornada completa

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Design Controls

Risk Management

V&V (Verification & Validation)

TRM/TMV (Technical Risk Management)

DFM (Design for Manufacturability)

Educación

Bachelor's degree in Engineering

Descripción del empleo

Role: Quality Engineer

Location: West Valley City, UT (100% Onsite)

Duration: 12+ Months

Position Overview

We are seeking an experienced Quality Engineer to support design quality, integration, and remediation initiatives within a regulated medical device environment. This role requires strong technical expertise in Design Controls, Risk Management, Verification & Validation (V&V), and Technical Risk Management (TRM/TMV), with the ability to independently develop, execute, and support quality engineering activities throughout the product lifecycle.

Key Responsibilities

• Support New Product Development (NPD) and Design Quality activities in compliance with FDA 21 CFR Part 820 and applicable quality standards.
• Lead and support Design History File (DHF) remediation and design integration projects.
• Develop and execute risk management activities, including risk assessments, hazard analyses, and mitigation strategies.
• Author and review design control documentation, V&V protocols, reports, and technical files.
• Support implementation of Design for Manufacturability (DFM) principles and quality improvements.
• Collaborate with cross-functional teams including R&D, Manufacturing, Regulatory Affairs, and Quality.
• Participate in major remediation and integration initiatives to ensure compliance and product quality.
• Support design transfer, change management, and lifecycle management activities.

Required Qualifications

• Bachelor s degree in Engineering or a related technical discipline.
• 4+ years of Quality Engineering experience within the medical device industry.
• Strong experience with Design Controls and FDA 21 CFR Part 820 requirements.
• Hands-on experience developing and executing Risk Management and Verification & Validation (V&V) activities.
• Experience supporting design integration, DHF remediation, and quality system improvement initiatives.
• Strong technical writing, problem-solving, and cross-functional collaboration skills.