Quality Engineer I

Carlsbad, CA 92008, United States

Job Description



Careers that Change Lives
A Day in the Life
MITG
The Minimally Invasive Therapies Group strives to enable earlier diagnosis, better treatment, faster complication-free recovery, and enhanced patient outcomes through less invasive surgical solutions.
RESPIRATORY INTERVENTIONS
Respiratory Interventions (RI) offers technologies to support patients in need of respiratory assistance through ventilation, airway access, and airway support accessories.
Develop and deliver the medical device breakthroughs that make a difference in the lives of millions of patients.
Does this work inspire you?
Work with design and manufacturing teams to make product and process changes to medical device equipment. Use quality engineering concepts, including but not limited to design control, process control, risk management, supplier quality, and continuous improvement.
Ensure desired design and product performance levels are met in compliance with all applicable regulatory requirements and Medtronic Policies and Procedures.
What is the work you will be doing?
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Learn the medical device industry requirements and guidance including the Quality System Regulation, ISO 13485, Medical Device Directive, Medical Device Regulation, ISO 14971, IEC 60601 and other standards.
Support the development of medical devices in conformance with these requirements.
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Assist in compiling trending and post market vigilance data for monthly meetings
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Ensure internal Design Control and Process Control policies and procedures are implemented on design and process change projects.
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Provide guidance on the application of internal procedures, including Design Control and Process Control, to the development teams, within the framework of regulatory requirements.
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Serve as project core team member representing Design Quality.
Interact and form constructive working relationships with development and manufacturing team members.
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As a core team member on change development projects, perform or contribute to the development of the following:
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Product Risk Assessments and Process Failure Mode Effects Analyses
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Design Updates
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Design Verification and Validation strategies and acceptance criteria
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Risk based sampling plans
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Process Capability Analyses
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Post Market Surveillance Reports
Must Have: Minimum Requirements

  • Bachelors degree required
  • 0 years of experience required
Nice to Have
\xc2\xb7 Proficiency in Microsoft Excel and Power point
\xc2\xb7 Basic scripting skills

About Medtronic

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let\xe2\x80\x99s work together to address universal healthcare needs and improve patients\xe2\x80\x99 lives. Help us shape the future.

Physical Job Requirements

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)

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Job Detail

  • Job Id
    JD4265229
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    Carlsbad, CA 92008, United States
  • Education
    Not mentioned