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Associate Design Quality Engineer

Applications are closed

  • Job
    Full-time
    Entry & Junior Level
  • Temecula

Requirements

  • Bachelors’ Degree in Engineering (Electrical Engineering degree preferred but not required), or related field, or the equivalent combination of education and experience
  • 0-2+ years’ related experience and/or training in a Quality and/or Development Position
  • Medical Devices experience preferred
  • Prior experience in compliance management within a rapid-growth, dynamic organization
  • Working knowledge of FDA, USDA and applicable non-US regulations pertaining to medical or pharmaceutical manufacturing

Responsibilities

  • Provides design assurance support in design and development of medical device products and facilitate the application of design controls and risk management.
  • Acts as a reviewer and approver of validation methods and protocols, test methods, statistical analysis methods and specification development.
  • Reviews new and modified product designs for quality.
  • Ensures that product development projects and changes to existing products are conducted in compliance with the FDA Quality System Regulation and Medical Device Directives.
  • Acts as a key contributor to development and validation plans and processes.
  • Acts as a key team member in establishing, communicating and mitigating risks.
  • Ensures successful transfer of new products to manufacturing.
  • Reviews production validation methods.
  • Reviews and approve verification and validation test plans.
  • Reviews design history files and technical files for conformance to applicable requirements.

FAQs

What is the job title of the position available at Abbott?

The job title is Associate Design Quality Engineer.

Where is the location of the job?

The job is located in Temecula, CA.

Is this position remote or onsite?

This is an onsite daily position.

What are the basic qualifications required for this role?

The basic qualifications include a Bachelor’s Degree in Engineering (preferably Electrical Engineering) or a related field, or an equivalent combination of education and experience, along with 0-2+ years of related experience and/or training in a Quality and/or Development Position.

Is experience in medical devices preferred for this position?

Yes, medical devices experience is preferred.

What responsibilities will an Associate Design Quality Engineer have?

Responsibilities include providing design assurance support for medical device products, reviewing validation methods and protocols, ensuring compliance with FDA Quality System Regulations, and facilitating the successful transfer of new products to manufacturing.

What types of benefits does Abbott offer?

Abbott offers a range of benefits including free medical coverage for employees, a retirement savings plan, tuition reimbursement, wellness programs, paid time off, and competitive compensation.

What kinds of development opportunities does Abbott provide?

Abbott provides career development opportunities, training programs for new employees, and tuition assistance for employees seeking further education.

What is the salary range for this position?

The base pay for this position is $48,000.00 – $96,000.00, although the pay range may vary in specific locations.

Is Abbott committed to diversity in the workplace?

Yes, Abbott is committed to employee diversity and is an Equal Opportunity Employer.

Science & Healthcare
Industry
10,001+
Employees

Mission & Purpose

At Abbott, we’re dedicated to helping people live more fully, in everything we do. We’re creating the future of healthcare through life-changing technologies that make you healthier and stronger, quickly identify when you have a medical need, and treat conditions to help you get back to doing what you love. With headquarters in north suburban Chicago, Abbott serves people in more than 160 countries with leading medical devices, diagnostics, nutrition products and branded generic medicines. More than 115,000 of us are helping millions of people to live better and healthier, every day around the world. Our employees do work that matters as part of a global community that supports them with career development opportunities and locally competitive benefits. Mission: We help people live better and healthier with our life-changing technologies. We're revolutionizing health with the most personal technologies, empowering people with the data and knowledge they need to help them live longer and better.

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