SoTalent

Description

Quality Systems Engineer

Salary Range: $80,000 - $110,000 annually (based on experience, location, and skillset)

Make a Real Impact in Healthcare Engineering

Join a mission-driven team committed to advancing the quality, safety, and reliability of life-sustaining medical technologies. This role is essential to the ongoing development and improvement of tools and processes that support critical patient care products. If you're looking for a position where your work matters-every day-you'll find purpose, challenge, and fulfillment here.

Position Overview

As a Quality Systems Engineer, you'll play a key role in ensuring that our manufacturing and quality systems operate within regulatory requirements and industry standards. You'll lead validation efforts, support new technology integration, and guide continuous improvement initiatives across multiple departments.

This role also focuses on software, systems, and process validation within a highly automated facility that manufactures essential healthcare delivery products.

Key Responsibilities

• Oversee equipment, software, and process validation in manufacturing and support areas.
• Develop and execute validation protocols, test cases, and documentation packages.
• Support quality initiatives through root cause analysis, risk assessments, and corrective/preventive actions (CAPA).
• Lead process capability studies and apply statistical methods to drive operational excellence.
• Partner with cross-functional teams on process enhancements, technology implementation, and automation projects.
• Ensure all computerized systems comply with regulatory requirements; may serve as subject matter expert in system validation.
• Provide engineering support to operations, including analysis of system performance and implementation of improvements.
• Coordinate with internal departments to ensure timely execution of quality-driven projects and system upgrades.
• Maintain compliance with federal, state, and internal quality and safety standards.
• Assist with audits, development of SOPs, and updates to technical documentation.
• Mentor junior team members and provide guidance on validation best practices.

Ideal Candidate Profile

• Bachelor's degree in Engineering, Computer Science, or a scientific discipline.
• 3-5 years of relevant industry experience in a quality, validation, or systems engineering capacity.
• Strong knowledge of validation methodology and regulatory requirements in a highly regulated environment.
• Experience with software and hardware validation, especially in production or life sciences settings.
• Familiarity with applications such as Wonderware, Allen-Bradley PLC/HMI, Microsoft Project, and Access is a plus.
• Understanding of lean manufacturing, Six Sigma, or related continuous improvement methodologies.
• Certified Quality Engineer (CQE) or Certified Software Quality Engineer (CSQE) preferred.
• Strong communication, organizational, and analytical skills.
• Comfortable working both independently and within multidisciplinary teams.

Compensation & Benefits

In addition to a competitive salary, the benefits package includes:

• Health Coverage: Medical, dental, and vision plans starting from day one.
• Time Off: 20+ days of paid time off annually, plus holidays and paid parental leave.
• Retirement: 401(k) plan with employer match.
• Stock Purchase Program: Discounted shares available through an employee purchase plan.
• Education Support: Tuition reimbursement and access to professional development resources.
• Wellness Programs: Life insurance, disability coverage, EAP, and wellness initiatives.
• Work-Life Balance: Flexible spending accounts, childcare assistance, commuter benefits, and more.

Please note: This job posting is just a preview of the full scope of the position. A comprehensive job description is shared by a member of our team.