Sr. Quality Engineer – Queretaro Site

Job Description:

• Verify company’s adherence to the established Quality System and GMP/ISO standards.
• Supports technical and statistical investigations concerning optimization and compliance to specification. Also, provide mentorship to lower level engineering positions.
• Creation and maintenance of Quality Plans and Reports. Also, provide mentorship to lower level engineering positions.
• Work with microbiology to ensure appropriate environmental monitoring and that microbiology requirements are considered in product and process development activities
  Owner of measuring process capability, process controls, and process validation / efforts.
• Completing and Documenting Monthly Quality Data Review, providing data analysis and escalation recommendations
• Owning, Executing, and authoring I 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. Our 114,000 colleagues serve people in more than 160 countries.
• Own, complete Completion and approval of document Change Requests, assuring accuracy, adequacy, and compliance to Quality System and product requirements
• Completion of risk management and risk analysis including FMEA. Also, provide mentorship to lower level engineering positions.
• Work with R&D/Design Quality to revise design verification and design validation plans for products based on performance specifications and risk analysis. Also, provide mentorship to lower level engineering positions.
• Conducting & Own NCMR Investigations, CAPAs, Calibration Out Of Tolerance (OOT) Investigations and Complaint Investigations (MA) related to manufacturing Process, Field Actions.
• Leading & Own Build At Risk (BAR) Authorizations & Closures

Required Qualifications

1. Individual should be innovative, resourceful, and work with minimal direction
2. Ability to travel approximately 10%, including internationally
3. Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
4. Strong organizational and follow-up skills, as well as attention to detail
5. Strong analytical, problem solving, and project management skills
6. Proficient with MS Office (Word, Excel, Outlook, PowerPoint)
7. Previous experience working in a highly matrixed and geographically diverse business environment
8. 5+ years manufacturing engineering experience in medical device or related industry, including working on and documenting process improvement initiatives
9. Bachelor’s Degree in Chemical, Industrial, or Mechanical Engineering, or other related discipline
10. Individual should have excellent organization, problem solving, communication, and team leadership skills

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