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Quality Assurance Analyst

2 months ago

Charlotte, North Carolina, United States Jobot Full time
Leading Medical Device Firm Seeking Quality Assurance Analyst

This position is hosted by Jobot.

About Us:

We are a rapidly expanding Medical Device firm with our headquarters in North America.

Why Work With Us?
  • Comprehensive Employer-paid Medical, Dental, and Vision Insurance
  • 4% 401K Match
  • 10 Paid Holidays and 3 Weeks of Paid Time Off to Start, increasing to 4 Weeks after one year of service


Position Overview:

We are looking for a proactive and skilled Quality Assurance Analyst to join our dynamic team. This role is essential in upholding the engineering excellence that defines our organization. The ideal candidate will be tasked with the implementation, monitoring, and enhancement of our Quality Management System (QMS) in accordance with industry best practices. You will collaborate with a diverse group of engineers and professionals to ensure the highest quality standards across all projects. This is a full-time, permanent role with competitive benefits.

Key Responsibilities:

1. Develop, implement, and sustain the Quality Management System (QMS) in alignment with industry standards.
2. Supervise all facets of the Medical Device Quality System, ensuring compliance with regulatory requirements.
3. Manage the Corrective and Preventive Action (CAPA) process, pinpointing areas of non-compliance and spearheading continuous improvement initiatives.
4. Create and maintain Standard Operating Procedures (SOPs) for all engineering processes.
5. Oversee Document Control, ensuring all documents are precise, current, and readily accessible.
6. Conduct regular audits of the QMS, identifying potential risks or areas of non-compliance.
7. Collaborate with various departments to integrate the QMS into all organizational areas.
8. Provide training and support to staff on quality assurance topics, fostering a culture of quality throughout the organization.
9. Generate detailed reports on QMS performance, presenting findings to senior management.
10. Stay informed on industry trends, regulations, and best practices, implementing necessary changes to the QMS.

Qualifications:

1. Bachelor's degree in Engineering, Quality Assurance, or a related discipline.
2. At least 5 years of experience in a Quality Assurance role within the Engineering sector.
3. Comprehensive knowledge of Quality Management Systems (QMS), including development, implementation, and maintenance.
4. Proven experience with the Medical Device Quality System, CAPA, SOP, and Document Control.
5. Strong understanding of industry regulations and standards.
6. Excellent analytical and problem-solving abilities, with a knack for identifying risks or non-compliance.
7. Strong communication skills, capable of conveying complex concepts clearly and concisely.
8. Exceptional organizational skills, with the capacity to manage multiple tasks simultaneously.
9. Proficient in Microsoft Office Suite, especially Excel and PowerPoint.
10. Certification as a Quality Engineer (CQE) or Quality Auditor (CQA) is a plus.

Join our team and contribute to a culture that prioritizes quality, innovation, and continuous improvement.