The 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 across the Organization.
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, Science 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
- Project experience with database migration
- MDSAP implementation
- Training/certification in lead auditing ISO 13485 and FDA GMP systems
Benefits
Competitive compensation package
Top Skills
What We Do
Nextern collaborates with innovators, clinicians, and device partners to create, iterate, optimize and manufacture best-in-class medical devices. We bring an unmatched core competence in medical device product design and development through manufacturing as a leverageable asset to collaborators like you, who are focused on accelerating the commercial side of the business.
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