JOB DESCRIPTION: 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 support/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/support Major Quality System investigations (i.e. CAPAs, HHEs, StopShip, etc.) and audits (External / Internal)
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.
MAIN RESPONSIBILITIES
- 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.)
- 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.
QUALIFICATIONS
- Bachelor Degree Engineering
- 4-6 years experience in Quality or Engineering positions.
- At least 4 years of experience in Quality or Manufacturing Engineering positions.
- Proficiency in computer applications (MS Excel, MS Word, MS PowerPoint).
- Knowledge of statistical/data analysis and report writing experience.
- Experience with control of nonconforming material, corrective and preventive actions as investigation owner and/or implementor.
- Experience working on FDA, GMP, and ISO 13485 Regulated environments.
- 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.
- Advance command of English required. Fluent oral and writing communication including technical writing.
JOB FAMILY:
Operations Quality
DIVISION:
SH Structural Heart
LOCATION:
Costa Rica Alajuela : Parque Industrial, Zona Franca Coyol S.A Edificio #44B, Call0, Avendia 2
ADDITIONAL LOCATIONS:
WORK SHIFT:
Cr09Sal (Costa Rica)
TRAVEL:
Yes, 10 % of the Time
MEDICAL SURVEILLANCE:
Yes
SIGNIFICANT WORK ACTIVITIES:
Work in a clean room environment
