Quality Process Engineer

Overview

Maintain and improve medical device manufacturing processes per ISO/FDA standards.

Key Responsibilities

• design changes
• value engineering
• eco management
• bom management
• ncr process
• component inspection

Tasks

-Develop, test, and implement design changes as well as coordinate with suppliers and manufacturers to ensure smooth implementation. -Provide technical resource regarding equivalency in value engineering and analysis for current components and future product development projects. -Manage ECO documentation release and Bill of Materials updates across multiple product lines. -Initiate and rationalize engineering changes from nonconforming component issues, suggesting changes for approval or rejection. -Prepare documentation with a high degree of accuracy, completeness, and effectiveness. -Work collaboratively with Quality team members to manage the NCR process including documentation, supplier communication, product returns, and rework, SCAR root cause investigations, and issue resolution. -Lead technical resource for Quality, RMA, and oversee component inspection and testing process to verify conformance with specifications. -Develop design recommendations to improve product reliability and performance. -Manage Bill of Materials across multiple product lines. -Create and revise incoming inspection documentation.

Requirements

• solidworks
• gd&t
• as 9100
• iso 9001
• excel
• bachelor’s

What You Bring

-Working knowledge of AS 9100, ISO 9001 and/or ISO preferred. -Experience with engineering change orders and manufacturing design. -Proficient in CAD with SolidWorks expertise preferred. -Mechanically inclined with an affinity for tools and measuring equipment. -Ability to organize and prioritize workflow across multiple projects to meet established time frames and schedules. -3+ years of experience in a manufacturing environment required. -Knowledge of manufacturing operations, process verification and validation, geometric dimensioning and tolerancing (GD&T) including the ability to create and understand prints and specifications. -Excellent communication and organizational skills working in cross-functional teams. -Proficient in Microsoft Office, with a good working knowledge of Excel. -Bachelor’s degree in Engineering (Mechanical, Manufacturing or Biomedical) required. -Proficient in GD&T, blueprint reading, quality management system, metrology, manufacturing process optimization & documentation.

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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