Costa Rica Job Openings
Nextern
Quality Systems Engineer
Cartago
FULL TIME
September 18, 2024
The Quality System Engineer will be responsible for maintaining and implementing process improvements to Nextern’s Global Quality System (QMS) procedures including supporting software configuration (Agile PLM). This position will also be responsible for supporting internal audits, data analysis, training, and implementation of Quality System Software Validation procedures.
DUTIES AND RESPONSIBILITIES:
Competitive compensation package
DUTIES AND RESPONSIBILITIES:
- Lead and facilitate global QMS procedure changes and process improvements required to align business processes or changes to industry standards and requirements.
- Support configuration activities of Agile PLM to support new or improved processes.
- Utilization of Project Management, Six Sigma, Lean or other disciplines to improve Quality System processes.
- Support stakeholders with software validation efforts.
- Support on-boarding of new employees with Quality System processes and Agile PLM setup.
- Prepare and analyze Quality System metrics for presentation to stakeholders and top management.
- Support internal, external and third-party audits.
- Performs other related duties as assigned by management.
- Bachelor’s Degree in Engineering or relevant area, plus 2-5 years of relevant experience in ISO 13485 and FDA GMP. Relevant experience aligns directly to the job specific responsibilities listed below:
- Experience with Quality System process improvement including project management
- Experience with document management
- Experience with data analysis and presenting to cross-functional teams and leadership.
- Fully bilingual Spanish-English
- Excellent skills in standard computer-based software programs such as Microsoft Office.
- Excellent learning agility.
- Must be self-motivated with ability to handle, organize and prioritize multiple tasks and able to perform under pressure to meet deadlines.
- Ability to effectively build and maintain relationships, communicate, and interact with a variety of personalities.
- Preferred Qualifications:
- Experience with database administration/configuration
- Agile PLM, Microsoft Power BI, Epicor (ERP) experience or other similar applications
- Project management experience
- Training/certification in Lean and Six Sigma
- Training/certification in lead auditing ISO 13485 and FDA GMP systems
Competitive compensation package
New Job Alerts
Western Union
Manager, Agent Regulatory Risk Operations
Santa Ana
FULL TIME
November 9, 2024
View Job Description
Looking for similar job?
Medtronic
Senior Quality Supervisor – Processes and Operations (Medical Devices Manufacturing)
Alajuela
FULL TIME
August 31, 2024
View Job Description
Bosch Group
QUALITY MANAGEMENT AND METHODS INTERN
San Francisco
FULL TIME
August 23, 2024
View Job Description
Smith & Nephew
Jr. Quality Engineer (Coyol, Costa Rica)
FULL TIME
August 30, 2024
View Job Description
Confluent Medical Technologies
Quality Assurance Engineer Senior Staff - P42-002
FULL TIME
August 29, 2024
View Job Description
Boston Scientific Corporation
Sr, Quality Systems Engineer Heredia
Heredia
August 28, 2024
View Job Description
See What’s New: Nextern Job Opportunities
Nextern
Senior Customer Success Specialist
Cartago
FULL TIME
September 16, 2024
View Job DescriptionNew Job Alerts
Western Union
Manager, Agent Regulatory Risk Operations
Santa Ana
FULL TIME
November 9, 2024
View Job Description