JOB DESCRIPTION:
MAIN PURPOSE OF ROLE
To integrate and maintain quality systems in Querétaro in accordance with all applicable regulations, standards and Abbott/AQ policies/Mexican regulations. This includes but no limited to proactive implementation and maintenance of compliance of the divisional quality system and site-specific procedures and practices, search and appliance of integration initiatives and improvements. This role is intended to work independently on the leadership within Querétaro for all-across application of the system and may have supervision responsibilities of direct reports within quality systems organization.
MAIN RESPONSIBILITIES
• Provides Quality System Body of Knowledge support to the organization.
• Lead cross functional teams to execute Quality System initiatives.
• As appropriate, participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality System function as a Team Member)
• Draft, review, and update Quality Systems support documentation to proactively comply with applicable internal, domestic, and international standards or regulations.
• Support and execute internal/external Quality System audits
• Ensures compliance to all Quality System Regulations and policies applicable to business units in Querétaro by providing support for interpretation of regulations, performing gap analysis and lead activities to implement improvements
• Identify opportunities for improvement regarding compliance to all Quality System Regulations and policies applicable to business units in Querétaro
• Supports, executes, and resolves investigations related either to non-conformances or improvement opportunities.
• Works with the organization during new product introductions to ensure quality deliverables, write Quality Plans and ensure Risk Management are in place for the products being transferred
• Evaluates regulations to translate requirements into user friendly Standard Operating Procedures and Work Instructions
• Supports the CAPA System elements for the site
• Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors
• Might be responsible for specific areas within the quality systems organization, driving for excellent operative execution and personnel management (facilitation, training and development)
• Performs other duties and responsibilities as assigned.
• Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Responsible for effective change request administration, proper application of ERP configuration control system, providing technical support to project teams as required, maintenance of documentation databases and enforcing adherence to written documentation policies and procedures
QUALIFICATIONS
Education Level : Bachelor Degree
Major/Field of Study : Engineering, Business Administration, or Science
Experience/Background
Experience: 4-6 years’ experience in Quality positions.
Experience Details:
• 2+ years in Quality Systems, Compliance positions, or demonstrated equivalent experience in Quality,
• +2 year of experience in an FDA (QSR), ISO 13485 or ISO 9001 controlled industry.
• Demonstrated knowledge of quality systems including but not limited to Training, Documentation, Testing and/or Quality Release
• Demonstrated experience in Quality, Engineering or work within structured processes, desirable in Medical Devices
• Exposure and application of regulations for Medical Devices (FDA-QSR, ISO13485) or experience in ISO9001.
• Knowledge and Application of process improvement such as: (Root Cause Analysis, Fishbone, Is/Is Not, etc.), Six Sigma or Process Control & Monitoring (SPC).
• Proficiency in computer applications (MS Excel, MS Word, MS PowerPoint).
Language Proficiency: Advance Commands of English / Required
Preferred Qualifications & Education :
- Quality Auditor training for ISO 13485 Lead Auditor or ISO9001
- Certified Quality Engineer or AAMI Quality Systems.
- Quality Systems related certifications (Quality Control, CAPA, Risk Management, etc).
- Certifications on any of the following (in progress or completed): Quality Management, Operational Excellence, Project Management or similar.
- 1-2 years of experience participating on ISO and/or FDA audits is a plus
Apply Now
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The base pay for this position is
N/A
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:Operations Quality
DIVISION:EP Electrophysiology
LOCATION:Mexico > Queretaro : Fray Junipero Serra 21260
ADDITIONAL LOCATIONS:
WORK SHIFT:Standard
TRAVEL:Not specified
MEDICAL SURVEILLANCE:Not Applicable
SIGNIFICANT WORK ACTIVITIES:Not Applicable
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