Senior Quality Systems Engineer

hace 2 semanas


Cartago, Costa Rica Nextern A tiempo completo

The Senior Quality System Engineer will be responsible for ensuring compliance with ISO 13485 and 21CFR 820 in the Quality System department in Nextern.
Prepare quality metrics for management reviews and support data analysis with process owners.
Actively participate in creating or improving QMS documentation, and ensuring solutions are implemented effectively.  This position will also be responsible for supporting internal audits, data analysis, training, and implementation of Quality System Software Validation procedures.
DUTIES AND RESPONSIBILITIES: Identify opportunities for process improvement, lead continuous improvement initiatives, and implement changes to enhance product quality and efficiency.
Global Issue Management and CAPA process owner, ensuring execution, accountability, and timeliness.
Monitor and measure the effectiveness of the Quality System and drive continuous improvement through Management Review and other appropriate forums.
Schedule and execute internal audit according to applicable regulations and standards.
Host external audits in a professional and knowledgeable manner.
Monitor regulation changes that affect the Quality System and ensure continued compliance.
Follow all Nextern's policies, practices and procedures to ensure that FDA and ISO regulations along with Nextern quality standards are met.
Support QMS processes across all Nextern functions.
Performs other related duties as assigned by management.
Requirements 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: E xperience with Quality System process improvement including project management E xperience with document management E xperience 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: E xperience with database administration/configuration Agile PLM, Microsoft Power BI, Epicor (ERP) experience or other similar applications Project management experience Project experience with database migration MDSAP implementation Training/certification in Lean and Six Sigma Training/certification in lead auditing ISO 13485 and FDA GMP systems Benefits Competitive compensation package



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