Quality Engineer IV

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 IV, 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. Own/support Major Quality System investigations (i.e. CAPAs, HHEs, StopShip, etc.) and audits (External / Internal).

You will also be responsible for support 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. Employee uses knowledge to propose alternatives tasks and to bring projects to completion.

What You’ll Do

• Verify Verify company’s adherence to the established Quality System and GMP/ISO standards.
• Completion of risk management and risk analysis including FMEA. Also, provide support 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 support to lower level engineering positions.
• Supports technical and statistical investigations concerning optimization and compliance to specification. Also, provide support 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 NCMR Investigations, Calibration Out Of Tolerance (OOT) Investigations and Complaint Investigations (MA) related to manufacturing Process.
• Works closely with Sr quality engineering position on completing and documenting Monthly Quality Data Review, providing data analysis and escalation recommendations.
• 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. Also, provide support to lower level engineering positions.
• Executing and authoring IQ, OQ, PQ, and/or PPQ Qualifications and Inspection and Test Method Qualifications, Also, provide support to lower level engineering positions.
• Conducting Advanced Statistical Data Analyses using Minitab. • Authoring Master Validation Plans and Reports.
• Supports activities during preparation and execution of audits (External / Internal), functioning as SME backup for specific Quality activities.
• Support Major Quality System investigations (i.e. CAPAs, HHEs, StopShip, etc.) Bachelor Degree
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. Support, coach, and mentor non-exempt and entry level exempt personnel. Creating and Communicating details and information of events related to quality to upper management. Participation as listener 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, if required.

Required Qualifications

• Bachelor’s Degree in STEM careers. Engineering preferred.
• 4-6 years of experience in related 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.
• Experience with control of nonconforming material, corrective and preventive actions.
• Experience working on FDA, GMP, and ISO 13485 regulations.
• Experience in process improvement tools such as: Root Cause Analysis, Fishbone, Is/Is Not, Six Sigma or Process Control & Monitoring (SPC), Quality Tools.
• Project management experience, participating or leading multi-departmental project teams.
• Advanced command of English language (required).

Shift ADM (Monday to Friday 8:00 am to 5:00 pm)

Works 100% on site

Preferred Qualifications

• Prior medical device industry experience.
• ASQ CQE / Six Sigma or similar certification.
• Participation or leading multi-departmental project teams.
• Experience in supervision role.
• Master's Degree on position related field.

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.

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:Costa Rica > Alajuela : Parque Industrial, Zona Franca Coyol S.A Edificio #44B, Call0, Avendia 2

ADDITIONAL LOCATIONS:

WORK SHIFT:Standard

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