Sr. Quality Engineer - Querétaro Site
About Abbott
Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to:
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Career development with an international company where you can grow the career you dream of.
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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.
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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.
MAIN PURPOSE OF ROLE
Works closely with Manufacturing and Engineering on sustaining activities to ensure compliance with the quality system requirements and achievement of Key Performance Indicators (i.e. NCMR’s, MA’s, Yield, Cost Reduction projects, etc.) and owns/lead process/product validation activities
Works closely with Research and Development and Regulatory Affairs personnel (internal or external) to obtained support on sustaining activities and during new product introduction to assure compliance with product and regulatory requirements.
Owns Major Quality System investigations (i.e. CAPAs, HHEs, StopShip, Audit finding, etc.) and audits (External / Internal)
Responsible for developing and maintaining quality engineering methodologies and providing quality engineering leadership and support for commercialized products, manufacturing, and/or system/services support.
Works with minimum supervision and assignments are broad in nature and employee uses discretion to design project task and to bring the project to completion.
MAIN RESPONSIBILITIES
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Verify company’s adherence to the established Quality System and GMP/ISO standards.
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Completion of risk management and risk analysis including FMEA. Also, provide mentorship to lower level engineering positions.
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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.
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Supports technical and statistical investigations concerning optimization and compliance to specification. Also, provide mentorship to lower level engineering positions.
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Owner of measuring process capability, process controls, and process validation / efforts.
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Work with microbiology to ensure appropriate environmental monitoring and that microbiology requirements are considered in product and process development activities.
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Conducting & Own NCMR Investigations, CAPAs, Calibration Out Of Tolerance (OOT) Investigations and Complaint Investigations (MA) related to manufacturing Process, Field Actions.
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Completing and Documenting Monthly Quality Data Review, providing data analysis and escalation recommendations.
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Leading & Own Build At Risk (BAR) Authorizations & Closures.
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Own, complete Completion and approval of document Change Requests, assuring accuracy, adequacy, and compliance to Quality System and product requirements.
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Creation and maintenance of Quality Plans and Reports. Also, provide mentorship to lower level engineering positions.
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Owning, Executing, and authoring IQ, OQ, PQ, and/or PPQ Qualifications and Inspection and Test Method Qualifications, Also, provide mentorship to lower-level engineering positions.
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Conducting Advanced Statistical Data Analyses using Minitab.
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Owning, create and authoring Master Validation Plans and Reports.
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Supports activities during preparation and execution of audits (External / Internal), functioning as SME for specific Quality activities.
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Own Major Quality System investigations (i.e. CAPAs, HHEs, StopShip, etc.) .
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Apply systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
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Lead, coach, and mentor non-exempt and entry level exempt personnel.
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Creating and communicating in a timely manner details and information of events related to quality to upper management.
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Leading and presenter on management meeting such as QDR, KPIs and Management Review.
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Perform other duties and responsibilities as assigned by senior management.
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Perform supervisor activities to Quality Technicians or Quality Engineers, if required.
QUALIFICATIONS
Education: Bachelor’s career : Engineering, Quality, Chemical, STEM (Science, Technology, Engineering, Math), biomedical, or related fields or Master's Degree on position related field (desirable)
Experience Details:
3 - 5 years experience in:
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Quality engineering positions within areas related to Quality in medical devices, pharmaceutical, or high technology industry.
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Experience on product and process qualification and transfer.
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Experience in conducting validations, qualifications, test methods or NCMR.
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Experience with control of non-conforming material, corrective and preventive actions as investigation owner and/or implementor.
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Experience in process improvement tools such as: (Root Cause Analysis, Fishbone, Is/Is Not, etc.), Six Sigma or Process Control & Monitoring (SPC).
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Experience on provide mentorship to lower-level engineering positions on Technical Writing.
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Statistical knowledge including statistical software e.g. Minitab, JMP.
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Experience with SAP.
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Participation or leading multi-departmental project teams.
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Quality auditor
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Detailed knowledge of FDA, GMP, and ISO 13485 or Lead Auditor ISO 13485.
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Experience on External and Internal audits.
Other Qualifications and Education
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Excellent interpersonal and communication skills.
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ASQ CQE / Six Sigma Blackbelt or similar certification.
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Proficiency in computer applications (MS Excel, MS Word, MS PowerPoint).
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ISO 13485 certification as Lead Auditor or similar.
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Project management experience.
Language proficiency : Advance Commands of English / Required. Fluent oral and writing communication including technical writing.
Apply Now
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 and @AbbottGlobal.
