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Senior Quality Systems Improvement Specialist
hace 1 mes
At Nextern, we are seeking a highly skilled Senior Quality Systems Improvement Specialist to join our team. This role will play a critical part in maintaining and implementing process improvements to our Global Quality System (QMS) procedures, including supporting software configuration (Agile PLM).
The ideal candidate will have experience with Quality System process improvement, project management, document management, data analysis, and presenting to cross-functional teams and leadership.
Key Responsibilities:
- Maintain and implement process improvements to QMS procedures
- Support configuration activities of Agile PLM to support new or improved processes
- Utilize Project Management, Six Sigma, Lean, and 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
- Analyze and prepare Quality System metrics for presentation to stakeholders and top management
- Support internal, external, and third-party audits
Requirements:
- Bachelor's Degree in Engineering or relevant area, plus 2-5 years of relevant experience in ISO 13485 and FDA GMP
- Fully bilingual Spanish-English
- Excellent skills in standard computer-based software programs such as Microsoft Office
- Excellent learning agility
- 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
Benefits:
This is a competitive compensation package position that includes salary ranging from $70,000 to $110,000 per year, depending on qualifications and experience.
