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Quality Assurance Engineer II

2 months ago

Plano, Texas, United States Abbott Laboratories Full time
About Abbott Laboratories

Abbott Laboratories is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines.

We have a team of 114,000 colleagues serving people in more than 160 countries.

Working at Abbott Laboratories

At Abbott Laboratories, you can do work that matters, grow, and learn, care for yourself and family, be your true self, and live a full life.

You'll also have access to:

  • Career development with an international company where you can grow the career you dream of.
  • Free medical coverage for employees via the Health Investment Plan (HIP) PPO.
  • An excellent retirement savings plan with high employer contribution.
  • Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree.
  • A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
  • A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
The Opportunity

This position works out of our location in the Neuromodulation Division.

Our Neuromodulation business includes implantable devices compatible with mobile technology to help people who suffer from chronic pain and movement disorders.

These non-opioid therapies allow us to provide interventional pain therapy to patients throughout the pain continuum.

Supplier Development Quality Engineers are responsible for activities related to supplier selection and evaluation, material qualification, supplier performance, and receiving inspection.

Supplier Development Quality Engineers drive improvement and corrective action in the quality of components sourced from outside suppliers.

This position contributes to the development, establishment, and maintenance of supplier quality engineering methodologies, systems, and practices that meet Abbott and regulatory requirements.

Each employee can make a difference at Abbott and has the power, either individually or as a team, to influence the success of the company.

We are team-oriented, fast-paced, and progressive.

We value people with great ideas who partner with others both internally and externally to take action and accomplish goals.

Key Responsibilities
  • Assesses supplier capabilities through direct visits, technical discussions, directed testing, and quality system audits.
  • Participates in supporting Supplier Development Quality program requirements (e.g., represents the Supplier Development Quality function as a Core Team Member).
  • Reviews new design specifications and provides inputs for component quality and manufacturability.
  • Mitigates risk by working with Suppliers to document Process Flow Charts, PFMEAs, and Control Plans.
  • Manages Supplier Change Requests, leading a cross-functional team.
  • Reviews and approves supplied product drawings and component quality plans.
  • Reviews and provides product inspection procedures and first article requirements.
  • Provides engineering guidance to Abbott Receiving Inspection, including statistical analysis, measurement techniques, Gage R&R studies, and inspection procedures.
  • Proactively communicates quality issues to Suppliers as needed through supplier quality system audits, supplier corrective action requests, and technical discussions.
  • Contributes and participates in supplier performance reviews.
  • Works with Manufacturing engineering to assess and address purchased product issues.
  • Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
  • Contributes to the development, maintenance, and improvement of Abbott supplier quality program policies, procedures, and forms.
  • Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
  • Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
  • Performs other related duties and responsibilities, on occasion, as assigned.
Requirements
  • Bachelor's degree or equivalent experience and education.
  • 2-5 years of related work experience with a good understanding of the specified functional area.
  • Preferred Qualifications:
    • 5 years of related work experience.
    • Previous medical device experience.
    • Master's Degree.