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Associate Quality Systems Specialist

Medtronic
USA-NJ Swedesboro Route 322, United Statesfull_timeVerifiedPosted 14 Nov 2024

About the role

We anticipate the application window for this opening will close on - 19 Nov 2024


 

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

Medtronic is hiring in Woolwich County, here our employees are helping us deliver on the extraordinary. We actively seek a diverse workforce at every level: We require fresh ideas and inclusive insights to maintain our position as an innovative industry leader. That’s why we actively seek, attract, and develop employees who are patient-centric, passionate, and who reflect the wide variety of life experiences found among our patients.
We’ve been on a three-year journey to modernize our U.S. distribution network and transform how we distribute our products. The Woolwich Distribution site is one of two new U.S. distribution hubs opened within the last year to enhance and streamline our delivery operations. We’re aiming to elevate the customer experience and generate cost savings with state-of-the-art technology and standardized processes. But none of it can happen without you – the people who power our operations and ensure that our customers receive our life-saving therapies when they need them.

Careers That Change Lives:

Around the world people rely on us to alleviate pain, restore health, and extend life.

They expect our products and services to be safe and effective.  As Associate Quality Specialist, you will be a member of the Distribution & Logistics Quality team. You will work with our current products and lead the quality assurance programs, policies, processes, procedures and controls to ensure our customers receive the Right Product, at the Right Place, in the Right Time and in the Right Way.

Our reputation as a company is based on the trust of our customers.  Quality is key to preserving that trust.

Come for a job, stay for a career.

A Day in the Life:

Responsibilities may include the following and other duties may be assigned.

  • Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established standards and agency guidelines.
  • Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and agency guidelines to assure compliance.
  • Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet guidelines.
  • Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.
  • Ensures the quality assurance programs and policies are maintained and modified regularly.
  • Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally.
  • Administers, evaluates and dispositions non-conforming product.
  • Investigates and provides recommendations for the resolution of quality issues.
  • Participates in process improvement initiatives. 
  • Maintains data and reports on performance metrics.

  • Must Have:  Minimum Requirements

  • Requires a bachelor’s degree in business or science.
  • 0-2 years of experience within a regulated environment

  • Nice to Have: 

  • 0-2 years’ experience within a quality role
  • 0-2 years’ medical device regulated industry experience
  • Knowledge/experience in the following areas:
    • CAPA Investigations
    • Non-conforming Product Dispositions
    • Product Hold Orders
    • ERP System Experience (e.g. SAP)
  • Bilingual (English/Spanish)

Physical Requirements:

The physical demands described here 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.

While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to stand; walk; and use hands to finger, handle, or feel objects, tools, or controls.  The employee is occasionally required to reach with hands and arms.  The employee must occasionally lift and/or move up to 30 pounds.  Specific vision abilities required by this job involve normal vision.

About Medtronic

Together, we can change healthcare worldwide. At Medtronic, we push

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Medtronic

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