Quality Engineer II
Abbott
JOB DESCRIPTION:
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 Costa Rica – Alajuela location in the 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.
As the Quality Engineer II - MES , you will work 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 support process/product validation activities. Works with Research and Development and Regulatory Affairs personnel (internal or external) to obtained support on sustaining activities to assure compliance with product and regulatory requirements. Support Major Quality System investigations (i.e. CAPAs, HHEs, StopShip, etc.) and audits (External / Internal).
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.
- Work with R&D/Design Quality to revise design verification and design validation plans for products based on performance specifications and risk analysis.
Conducts technical and statistical investigations concerning optimization and compliance to specification.
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 NCMR Investigations, Calibration Out Of Tolerance (OOT) Investigations and Complaint Investigations (MA) related to manufacturing Process
Conducting NCMR Investigations, Calibration Out Of Tolerance (OOT) Investigations and Complaint Investigations (MA) related to manufacturing Process
Leading Build At Risk (BAR) Authorizations & Closures
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, typically with minor mentorship from higher level engineering.
Support execution and approval of IQ, OQ, PQ, and/or PPQ Qualifications and Inspection and Test Method Qualifications, with mentorship from higher level engineering.
Conducting Advanced Statistical Data Analyses using Minitab with minimum mentorship from higher level engineering.
Maintenance/update/Authoring Master Validation Plans and Reports
Support/owns Major Quality System investigations (i.e. CAPAs, HHEs, StopShip, etc.) with mentorship from higher level engineering.
Required Qualifications
- Bachelor’s Degree in STEM careers. Engineering preferred.
- 1-2 years of experience in quality or engineering positions.
- Proficiency in computer applications (MS Excel, MS Word, MS PowerPoint).
- Knowledge of statistical, data analysis.
- Knowledge in process improvement tools such as: Root Cause Analysis, Fishbone, Is/Is Not, Six Sigma or Process Control & Monitoring (SPC), Quality Tools.
- Knowledge with control of nonconforming material, corrective and preventive actions.
- Knowledge of FDA, GMP, and ISO 13485 regulations.
- Advanced command of English language.
Preferred Qualifications
- Prior medical device industry experience.
- Previous Quality Engineering experience.
- Experience with SAP ERP System.
- Knowledge on product and process qualification and validation.
SHIFT Admin (Monday to Friday 8:00 am to 5:00 pm)
Works 100% on site
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.
The base pay for this position is
N/AIn specific locations, the pay range may vary from the range posted.
JOB FAMILY:
Operations Quality
DIVISION:
EP Electrophysiology
LOCATION:
Costa Rica > Alajuela : Parque Industrial, Zona Franca Coyol S.A Edificio #44B, Call0, Avendia 2
ADDITIONAL LOCATIONS:
WORK SHIFT:
Cr09Sal (Costa Rica)
TRAVEL:
Not specified
MEDICAL SURVEILLANCE:
Yes
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday), Work in a clean room environment