Plant Quality Engineer III (Medical Devices)

TL;DR

Plant Quality Engineer III (Medical Devices): Supporting a medical device manufacturing plant by ensuring Quality System compliance, validating processes, and improving manufacturing quality with an accent on pFMEA, CAPA investigations, process capability studies, and regulatory requirements. Focus on solving quality issues with operations, implementing corrective actions, and preparing controlled protocols, reports, quality plans, and work instructions.

Location: Onsite in Stuarts Draft, Virginia, United States; flexible start and stop times across all shifts, with movement throughout the manufacturing floor and occasional travel.

Salary: $65,000–$115,000 per year, depending on education and experience.

Company

hirify.global is an employee-owned healthcare products manufacturer specializing in ostomy care, continence care, and critical care products.

What you will do

• Support change controls and lead pFMEA, product qualification, and process qualification activities.
• Investigate and disposition non-conforming materials, CAPAs, and quality notifications through root cause analysis and corrective action.
• Plan, execute, and document process capability, validation, and process improvement studies.
• Prepare protocols, final reports, summaries, quality plans, and work instructions.
• Partner with operations and Value Stream Process Engineers to identify and resolve manufacturing quality issues.
• Conduct defect-awareness training and support plant and GQM strategic projects.

Requirements

• 0–5 years of overall experience; quality engineering or equivalent industry experience is preferred.
• Bachelor’s degree in engineering, mathematics, natural sciences, or a related field is preferred.
• Knowledge of medical device Quality System requirements, including FDA regulations and ISO 13485; experience with 21 CFR 820 is preferred.
• Knowledge of basic statistics, experimental design, process validation, and statistical software such as Minitab.
• Basic technical writing, written and oral communication, training, and facilitation skills.
• English proficiency is required; the role requires onsite work across a manufacturing facility and the ability to occasionally move products or parts weighing up to 20 pounds.

Nice to have

• ASQ Certified Quality Engineer certification.
• Lean and Six Sigma Black Belt principles.
• Experience with audits, product design regulatory requirements, self-directed work teams, SAP/ERP systems, and Microsoft Office.

Culture & Benefits

• Employee-owned company focused on making life more rewarding and dignified for healthcare product users.
• Work in a regulated medical device manufacturing environment with collaboration across operations and quality functions.
• Flexible start and stop times across all shifts.
• Role includes training and facilitation responsibilities, computer-based work, manufacturing floor activity, and occasional travel.