Senior Quality Engineer

apartmentAbbott Laboratories placePlano calendar_month 

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and your 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.
  • Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
  • An excellent retirement savings plan with a 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 worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works out of our Plano, TX 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.

What You’ll Work On
  • Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements.
  • Lead in the implementation of quality system processes and CAPA systems designed to meet or exceed internal and external requirements.
  • Assist in the planning, development, and execution of streamlined business Quality Systems which effectively identify and resolve quality issues.
  • Lead execution of medical device field actions and health hazard evaluations.
  • Communicates with regulatory agencies worldwide regarding quality system and quality issues.
  • Lead, coach, and mentor non-exempt and entry level exempt personnel
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
  • Appropriately document experiment plans and results, including protocol writing and reports
  • Lead and implement various product and process improvement methodologies (e.g., Six Sigma, Kaizen and Lean Manufacturing)
  • Lead the investigation, resolution and prevention and recurrence of product and process nonconformances
  • Support internal and external inspections
  • Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member)
  • Performs other related duties and responsibilities, on occasion, as assigned
  • Analyze Quality System data and present established metrics to senior and executive management
Required Qualifications
  • Bachelor's Degree Engineering or Technical Field
  • 3-5 years of engineering experience and demonstrated use of Quality tools/methodologies.
  • Detailed knowledge of FDA, GMP, ISO 13485, EUMDR and ISO 14971.
  • Solid communication and interpersonal skills.
  • Strong project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner. Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing).
  • Advanced computer skills, including statistical/data analysis and report writing skills. Prior medical device experience required.
  • Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing).

Apply Now

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott, and on Twitter @AbbottNews.

The base pay for this position is $72,700.00 – $145,300.00. In specific locations, the pay range may vary from the range posted.

apartmentTestrig TechnologiesplaceDallas, 6 mi from Plano
  0.  5 yr of experience in Manual or Automation testing Automation tester : should have good experience in Selenium, Java and TestNG Manual tester : should have good experience and understanding of functional and API testing should have good...
apartmentMichael PageplaceBedford (TX), 27 mi from Plano
and permanent forms of AF. Job Description The Senior Quality Engineer (Software Medical Devices) Will:  •  Represent Quality Engineering in all phases of design activity, including development, verification, validation, transfer, and design reviews for new...
apartmentAccord Tecnologies.IncplaceFort Worth, 41 mi from Plano
Title: Aerospace Supplier Quality Engineer Location: Fort Worth, TX (Onsite Only) No of positions: 1 Duration: 1 Year and likely to extend further The SQE core responsibilities will be communicating with suppliers, validating concerns, root...