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Quality Assurance Specialist

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Actalent

11d ago

  • Job
    Full-time
    Mid & Senior Level
  • Healthcare
  • Longmont

AI generated summary

  • You need 3-5+ years in Quality Assurance, experience in electro-mechanical industries, complaint management, CAPA/NCR knowledge, and strong technical writing and documentation skills.
  • You will support quality assurance processes across various departments, ensuring compliance and effectiveness within the quality team.

Requirements

  • 3-5+ year's Experience within Quality Specialist/Quality Assurance Roles
  • Experience Working in Electro-Mechanical Industry or High Tolerance
  • Background Managing Complaints - Writing, Creating Complaints, Tracking, etc
  • Experience Working with CAPA's/NCRs
  • Skilled in Technical Writing (Creating SOPs)
  • Documentation Experience

Responsibilities

  • Supporting key quality assurance processes throughout the quality team and diverse departments.

FAQs

What is the primary responsibility of the Quality Assurance Specialist?

The primary responsibility includes supporting key quality assurance processes throughout the quality team and diverse departments within the medical device manufacturer.

What qualifications are required for this position?

Candidates should have 3-5+ years of experience in Quality Specialist or Quality Assurance roles, preferably within the electro-mechanical industry or high tolerance environments, and experience managing complaints, CAPA's, and NCRs.

Is experience with FDA regulations necessary?

Yes, understanding FDA regulations is essential for this role, as well as experience working through SOPs and quality documentation.

What skills are considered top priorities for this role?

The top skills desired include quality assurance expertise, experience with ISO 13485, strong documentation skills, and technical writing capabilities, particularly in creating SOPs.

How does Actalent approach diversity and inclusion?

Actalent fosters a culture of diversity and inclusion by hiring diverse talent, maintaining an inclusive environment, building a culture of care and recognition, and providing growth opportunities for all employees.

Is technical writing experience required?

Yes, candidates should be skilled in technical writing, specifically in creating and managing standard operating procedures (SOPs) and other documentation.

Does the company provide reasonable accommodations during the application process?

Yes, applicants can request reasonable accommodations for the application or interviewing process due to a disability by emailing actalentaccommodation@actalentservices.com.

What type of industry experience is preferred for this role?

Experience in the electro-mechanical industry or high tolerance environments is preferred.

Are there opportunities for growth within the company?

Yes, Actalent emphasizes growth opportunities for its people as part of their commitment to a culture of care and engagement.

Is prior experience managing complaints a requirement?

Yes, candidates should have a background in managing complaints, which includes writing, creating, and tracking complaints effectively.

An Engineering and Sciences Services Company | People to Possible

Human Resources
Industry
5001-10,000
Employees

Mission & Purpose

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent’s global footprint and flexible delivery models ensure access to specialized talent where and when you need it. We promote consultant engagement through professional development and provide experiences to ensure continuous learning. Our people are the difference. Our expertise spans capabilities in engineering including product and manufacturing, systems and software, construction management, environmental, architecture and civil; and power and utilities. We focus on sciences capabilities in laboratory sciences, healthcare, and clinical research. Actalent is an operating company of Allegis Group, the global leader in talent solutions.