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Quality Systems Engineer
hace 2 meses
Job Summary:
The Sr. Quality Systems Engineer is a key member of the Medline team responsible for ensuring the development, implementation, and maintenance of our Quality Management System (QMS) in accordance with MDSAP, ISO13485, and FDA 21CFR Part 820 regulations. This position requires a strong understanding of quality systems standards and regulations in the medical device manufacturing environment.
Key Responsibilities:
- Develop and implement the internal audit program to ensure compliance with regulatory requirements.
- Act as Auditor Leader during corporate internal audits, FDA, BSI, and customer audits across all areas of the business.
- Manage Document Control activities through the EtQ Reliance system to ensure its effectiveness.
- Coordinate and follow up the CAPA system to ensure timely and effective resolution of quality issues.
- Lead quality projects improvements based on quality data trends to drive business growth and improvement.
- Perform gap assessments to identify areas for improvement and implement corrective actions.
- Support the goals and objectives of the organization within the Mexicali facility.
- Revise QA complaints in SAP module and interface with the corporate complaint department for review.
- Provide training to new employees on the Quality System and EtQ Reliance.
- Support in the planning and execution of Quality Week activities.
Requirements:
- Bachelor's Degree in Engineering or equivalent 3-5 years of experience in Medical Device Quality Systems.
- English fluency (85-90%).
- Experience in Internal/External Audits.
- Knowledge of ISO13485, MDSAP, and FDA 21CFR820.
- Problem-Solving Skills.
- Certified as an Internal Auditor (preferably).
- Office Windows: Word, Excel, Power Point, etc.
- ETQ Reliance, AS400 ERP Systems (AS400, SAP).
Preferred Qualifications:
- Communication.
- Teamwork.
- Proactive.
- Results Oriented.
- Sense of urgency.
- Organized.
- Responsible.
