Quality Engineer II

2 weeks ago

Plano, Texas, United States Abbott Full time
About the Role

Abbott 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 are a team-oriented, fast-paced and progressive company that values people with great ideas who partner with others both internally and externally to take action and accomplish goals.

Key Responsibilities
  1. Assess supplier capabilities through direct visits, technical discussions, directed testing and quality system audits
  2. Participate in supporting Supplier Development Quality program requirements
  3. Review new design specifications and provide inputs for component quality and manufacturability
  4. Mitigate risk by working with Suppliers to document Process Flow Charts, PFMEAs, and Control Plans
  5. Manage Supplier Change Requests, leading a cross-functional team
  6. Review and approve supplied product drawings and component quality plans
  7. Review and provide product inspection procedures and first article requirements
  8. Provide engineering guidance to Abbott Receiving Inspection including statistical analysis, measurement techniques, Gage R&R studies and inspection procedures
  9. Proactively communicate quality issues to Suppliers as needed through supplier quality system audits, supplier corrective action requests and technical discussions
  10. Contribute and participate in supplier performance reviews
  11. Work with Manufacturing engineering to assess and address purchased product issues
  12. Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
  13. Contribute to the development, maintenance and improvement of Abbott supplier quality program policies, procedures and forms
  14. Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments
  15. Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors
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
About Abbott

At Abbott, you can have a good job that can grow into a great career. We offer training and career development, with onboarding programs for new employees and tuition assistance. Financial security through competitive compensation, incentives and retirement plans. Health care and well-being programs including medical, dental, vision, wellness and occupational health programs. Paid time off. 401(k) retirement savings with a generous company match. The stability of a company with a record of strong financial performance and history of being actively involved in local communities.

Abbott is an Equal Opportunity Employer, committed to employee diversity. We provide reasonable accommodation to qualified individuals with disabilities. To request accommodation, please call or email [insert contact information].

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