Sr. Quality Engineer
Queretaro site in Mexico
**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:
- Career development with an international company where you can grow the career you dream of.
- 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.
- 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.
**The Opportunity**
This position works out of our Queretaro site in Mexico in EP Division. In Abbott's Electrophysiology (EP) business, we're advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives.
The Sr. Quality Engineer works closely with Manufacturing and Engineering on sustaining activities to ensure compliance with the quality system requirements and achievement of Key Performance Indicators 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.
**What You'll Do**
- Verify company's adherence to the established Quality System and GMP/ISO standards.
- 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.
- Supports technical and statistical investigations concerning optimization and compliance to specification. Also, provide mentorship to lower level engineering positions.
- Owner of measuring process capability, process controls, and process validation / efforts.
- Work with microbiology to ensure appropriate environmental monitoring and that microbiology requirements are considered in product and process development activities
- Conducting & Own NCMR Investigations, CAPAs, Calibration Out Of Tolerance (OOT) Investigations and Complaint Investigations (MA) related to manufacturing Process, Field Actions.
- Completing and Documenting Monthly Quality Data Review, providing data analysis and escalation recommendations
- Leading & Own Build At Risk (BAR) Authorizations & Closures
- Own, complete Completion and approval of document Change Requests, assuring accuracy, adequacy, and compliance to Quality System and product requirements
- Creation and maintenance of Quality Plans and Reports. Also, provide mentorship to lower level engineering positions.
- 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.
- Conducting Advanced Statistical Data Analyses using Minitab
- Owning, create and authoring Master Validation Plans and Reports
- Supports activities during preparation and execution of audits (External / Internal), functioning as SME for specific Quality activities.
- Own Major Quality System investigations (i.e. CAPAs, HHEs, StopShip, etc.)
- Lead, coach, and mentor non-exempt and entry level exempt personnel.
- Creating and communicating in a timely manner details and information of events related to quality to upper management.
- Leading and presenter on management meeting such as QDR, KPIs and Management Review
- Perform other duties and responsibilities as assigned by senior management.
- Perform supervisor activities to Quality Technicians or Quality Engineers, if required.
**Required Qualifications**
- ** Education**
- STEM (Science, Technology, Engineering (preferred), Math) (with equivalent experience in medical devices or pharmaceutical quality control)
- Bachellor Degree (University Level)
**Experience**
5-7 years experience in Quality Engineering positions.
- At least 5 years