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Urgent! Quality System Manager Job Opening In Monroe – Now Hiring Greiner
Your challenge
The Quality System Manager is responsible for overseeing the quality management system (QMS) to ensure compliance with regulatory standards, improve process efficiency, and maintain product quality.
This role focuses on managing the electronic quality document system (eQMS), Corrective and Preventive Actions (CAPAs), change control processes, and audit programs.
• Electronic Quality Document System (eQMS) Management:
o Oversee the implementation, maintenance, and continuous improvement of the eQMS to ensure regulatory compliance.
o Manage document control, including the review, approval, and maintenance of SOPs and controlled documents.
o Collaborate with document owners to ensure efficient and compliant procedures that facilitate cross-functional integration.
• Corrective and Preventive Actions (CAPA):
o Oversee the CAPA process, ensuring thorough investigation, root cause analysis, and timely completion of corrective actions.
o Lead the CAPA Review Board to discuss ongoing issues, drive timely closure, and communicate CAPA metrics to senior management.
o Conduct and review CAPA effectiveness checks, ensuring corrective actions are adequate and sustainable.
• Change Control:
o Manage change control activities, ensuring that changes are documented, evaluated for risk, and implemented in compliance with QMS.
o Provide guidance and support for change control processes across departments to ensure consistency and effectiveness.
• Quality System Compliance and Continuous Improvement:
o Ensure that quality system processes comply with FDA, ISO 13485, and ISO 9001 requirements.
o Identify and implement continuous improvement initiatives to enhance QMS efficiency and effectiveness.
o Facilitate training sessions and provide mentorship to staff on QMS elements, CAPA processes, audits, and change control.
Your Profile
• Bachelor’s degree in Engineering, Life Sciences, or related field; advanced degree preferred.
• 5-8 years of experience in the medical device industry, with a strong background in QMS, CAPA, audits, and regulatory compliance (ISO 13485, 21 CFR 820).
• Proven experience for implementation and maintenance of electronic Quality Management software.
Experience with implementation MasterControl preferred.
• Demonstrated leadership and project management skills with a track record in quality system management.
• Strong knowledge of FDA and ISO quality standards and the ability to lead regulatory compliance initiatives.
Our Offer
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Unlock Your Quality System Potential: Insight & Career Growth Guide
Real-time Quality System Jobs Trends in Monroe, United States (Graphical Representation)
Explore profound insights with Expertini's real-time, in-depth analysis, showcased through the graph below. This graph displays the job market trends for Quality System in Monroe, United States using a bar chart to represent the number of jobs available and a trend line to illustrate the trend over time. Specifically, the graph shows 27572 jobs in United States and 40 jobs in Monroe. This comprehensive analysis highlights market share and opportunities for professionals in Quality System roles. These dynamic trends provide a better understanding of the job market landscape in these regions.
Great news! Greiner is currently hiring and seeking a Quality System Manager to join their team. Feel free to download the job details.
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An organization's rules and standards set how people should be treated in the office and how different situations should be handled. The work culture at Greiner adheres to the cultural norms as outlined by Expertini.
The fundamental ethical values are:The average salary range for a Quality System Manager Jobs United States varies, but the pay scale is rated "Standard" in Monroe. Salary levels may vary depending on your industry, experience, and skills. It's essential to research and negotiate effectively. We advise reading the full job specification before proceeding with the application to understand the salary package.
Key qualifications for Quality System Manager typically include Operations Specialties Managers and a list of qualifications and expertise as mentioned in the job specification. Be sure to check the specific job listing for detailed requirements and qualifications.
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Here are some tips to help you prepare for and ace your job interview:
Before the Interview:To prepare for your Quality System Manager interview at Greiner, research the company, understand the job requirements, and practice common interview questions.
Highlight your leadership skills, achievements, and strategic thinking abilities. Be prepared to discuss your experience with HR, including your approach to meeting targets as a team player. Additionally, review the Greiner's products or services and be prepared to discuss how you can contribute to their success.
By following these tips, you can increase your chances of making a positive impression and landing the job!
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