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: 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.
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 Training/certification in Lean and Six Sigma Training/certification in lead auditing ISO 13485 and FDA GMP systems Benefits Competitive compensation package
