| Urgent Hiring :Medical Device Quality Engineer, Santa Rosa, CA ( Hybrid) at Santa Rosa, California, USA |
| Email: [email protected] |
| From: sujata, Vyzeinc [email protected] Reply to: [email protected] Job Title - Medical Device Quality Engineer Job Location - Santa Rosa, CA ( Hybrid) Visa - USC GC MOI - Skype Duration - 3 Months Department: Quality Assurance Reports To: Quality Assurance Manager / Director of Quality Need for 3 Quality Engineers to perform CAPAs for a Med Device Company in Santa Rosa, CA Position Overview: The Medical Device Quality Engineer will play a crucial role in ensuring the quality and compliance of our medical devices and pharmaceutical products. This individual will be responsible for conducting root cause analysis, developing and implementing Corrective and Preventive Actions (CAPAs), and driving continuous improvement initiatives within our manufacturing processes. Root Cause Analysis: Conduct thorough investigations into quality issues, deviations, and non-conformities. Utilize root cause analysis techniques such as 5 Whys, Fishbone Diagram, and Failure Mode and Effects Analysis (FMEA) to identify underlying issues. Collaborate with cross-functional teams to analyze data, perform investigations, and validate findings. Corrective and Preventive Actions (CAPAs): Develop, implement, and manage CAPAs to address identified issues and prevent recurrence. Ensure CAPAs are documented comprehensively and aligned with regulatory requirements and industry standards. Monitor and track the effectiveness of CAPAs to ensure successful resolution of quality issues. Compliance and Documentation: Ensure compliance with FDA regulations, ISO standards (e.g., ISO 13485), and other relevant regulatory requirements. Maintain accurate and detailed records of investigations, CAPAs, and quality assurance activities. Prepare and present quality reports, trends, and metrics to senior management and stakeholders. Continuous Improvement: Identify opportunities for process improvements and work with manufacturing teams to implement changes. Lead or support internal and external audits, inspections, and assessments. Stay current with industry trends, regulations, and best practices to ensure the highest quality standards. Collaboration and Communication: Work closely with engineering, production, and regulatory teams to address quality concerns and support product development. Provide training and guidance to team members on quality standards, procedures, and best practices. Communicate effectively with suppliers, customers, and regulatory bodies regarding quality issues and resolutions. Qualifications: Education: Bachelors degree in Engineering (Biomedical, Mechanical, Industrial), Quality Assurance, or a related field. Advanced degrees or certifications (e.g., CQE, CQA) are a plus. Experience: Minimum of [X] years of experience in quality engineering within the medical device or pharmaceutical manufacturing industry. Skills: Proficiency in root cause analysis techniques and CAPA management. Strong understanding of regulatory requirements (e.g., FDA, ISO) and industry standards. Excellent problem-solving, analytical, and communication skills. Ability to work independently and as part of a cross-functional team. Familiarity with statistical analysis tools and software (e.g., Minitab) is an advantage Keywords: green card California Urgent Hiring :Medical Device Quality Engineer, Santa Rosa, CA ( Hybrid) [email protected] |
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| Fri Jul 26 03:22:00 UTC 2024 |