Design Assurance Quality Engineer

Overview

Ensures quality compliance for electrode devices via verification, validation, risk mgmt & CAPA.

Key Responsibilities

• process validation
• risk management
• capa investigation
• kpi reporting
• change control
• quality plans

Tasks

-Investigate root causes of quality and yield issues in manufacturing and field environments. -Apply quality engineering tools such as process validation, equipment qualification, test method validation, sampling plans, and risk mitigation strategies. -Represent quality interests on project teams and during regulatory audits. -Ensure timely completion of post-market surveillance reviews and documentation. -Provide technical guidance and oversight to Quality Engineers. -Lead risk management activities, including development and maintenance of risk files in compliance with ISO 14971. -Provide quality trending data for management reviews and KPI reporting. -Develop and implement quality plans for products and processes. -Participate in CAPA investigations using systematic problem-solving methodologies. -Review and approve verification and validation protocols and reports. -Participate in change control review and approval activities.

Requirements

• microsoft office
• iso 13485
• iso 14971
• iec 62304
• fda qsr
• bachelor's

What You Bring

-Ability to manage multiple priorities in a fast-paced environment. -Excellent communication and interpersonal skills. -Proficient in Microsoft Office Suite. -Working knowledge of EN ISO 13485, ISO 14971, IEC 62304, and FDA QSR. -Education: Bachelor’s degree in Engineering or a technical discipline required. -Familiarity with mechanical and electrical test equipment. -Experience: Minimum 5 years in medical device quality engineering. -Strong understanding of medical device manufacturing practices. -High-energy problem solver with strong analytical skills.

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Benefits

-Medical, dental & vision -Health Spending Account (HSA) -Short and long-term disability -Critical Illness, Accident, and Hospital -401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available -Employee Assistance Program -Life Insurance (Voluntary Life & AD&D for the employee and dependents) -Transportation benefits -Time Off/Leave (PTO, Vacation or Sick Leave)

About Actalent

-Born in July 2021 by merging Aerotek’s engineering & sciences arm with EASi, Actalent emerged as a focused engineering-and-science partner. -Backed by Allegis Group, it drives scale and speed to market via contract, managed, and technical services. -Headquartered in Maryland with global reach, it deploys specialized teams across North America, Europe, and APAC on Fortune 500 projects. -Typical engagements span EV design, vaccine development, lab services, clinical research, and infrastructure systems. -Expertise covers a wide spectrum: aerospace, defense, healthcare, manufacturing, software systems, environmental and civil engineering.

Sector Specialisms