Quality Assurance Specialist at Jobot
Fort Mill, SC 29715
About the Job
Top Medical Device Company seeking QA Specialist
This Jobot Job is hosted by: Tyler Mase
Are you a fit? Easy Apply now by clicking the "Quick Apply" button
and sending us your resume.
Salary: $90,000 - $120,000 per year
A bit about us:
Growing Medical Device Company with North American HQ.
Why join us?
Job Details
Job Details:
We are seeking a dynamic and experienced Quality Assurance Specialist to join our team. This role is pivotal in ensuring the engineering excellence that our company is known for. The successful candidate will be responsible for implementing, monitoring, and improving our Quality Management System (QMS) in line with the industry's best practices. You will be working with a diverse team of engineers, and other professionals to maintain the highest quality standards in all our projects. This is a full-time permanent position with excellent benefits.
Responsibilities:
1. Develop, implement, and maintain the Quality Management System (QMS) in compliance with industry standards.
2. Oversee all aspects of the Medical Device Quality System, ensuring adherence to regulatory requirements.
3. Manage the Corrective and Preventive Action (CAPA) process, identifying areas of non-compliance and driving continuous improvement initiatives.
4. Develop and maintain Standard Operating Procedures (SOPs) for all engineering processes.
5. Manage Document Control, ensuring all documents are accurate, up-to-date, and easily accessible.
6. Conduct regular audits of the QMS, identifying any areas of risk or non-compliance.
7. Collaborate with other departments to facilitate the integration of the QMS into all areas of the organization.
8. Provide training and guidance to staff on quality assurance matters, promoting a culture of quality throughout the organization.
9. Generate comprehensive reports on the performance of the QMS, presenting findings to senior management.
10. Stay updated on industry trends, regulations, and best practices, implementing any necessary changes to the QMS.
Qualifications:
1. Bachelor's degree in Engineering, Quality Assurance or a related field.
2. Minimum of 5 years of experience in a Quality Assurance role within the Engineering industry.
3. In-depth 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 skills, with the ability to identify areas of risk or non-compliance.
7. Strong communication skills, with the ability to explain complex concepts in a clear and concise manner.
8. Excellent organizational skills, with the ability to manage multiple tasks simultaneously.
9. Proficient in Microsoft Office Suite, particularly Excel and PowerPoint.
10. Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) will be an added advantage.
Join us and be part of a team that values quality, innovation, and continuous improvement. We are excited to see your application!
Interested in hearing more? Easy Apply now by clicking the "Quick Apply" button.
This Jobot Job is hosted by: Tyler Mase
Are you a fit? Easy Apply now by clicking the "Quick Apply" button
and sending us your resume.
Salary: $90,000 - $120,000 per year
A bit about us:
Growing Medical Device Company with North American HQ.
Why join us?
- 100% Employer paid Med, Dental, Vision
- 4% match on 401K
- 10 paid holidays and 3 weeks PTO to start, goes to 4 weeks after 1 year of employment
Job Details
Job Details:
We are seeking a dynamic and experienced Quality Assurance Specialist to join our team. This role is pivotal in ensuring the engineering excellence that our company is known for. The successful candidate will be responsible for implementing, monitoring, and improving our Quality Management System (QMS) in line with the industry's best practices. You will be working with a diverse team of engineers, and other professionals to maintain the highest quality standards in all our projects. This is a full-time permanent position with excellent benefits.
Responsibilities:
1. Develop, implement, and maintain the Quality Management System (QMS) in compliance with industry standards.
2. Oversee all aspects of the Medical Device Quality System, ensuring adherence to regulatory requirements.
3. Manage the Corrective and Preventive Action (CAPA) process, identifying areas of non-compliance and driving continuous improvement initiatives.
4. Develop and maintain Standard Operating Procedures (SOPs) for all engineering processes.
5. Manage Document Control, ensuring all documents are accurate, up-to-date, and easily accessible.
6. Conduct regular audits of the QMS, identifying any areas of risk or non-compliance.
7. Collaborate with other departments to facilitate the integration of the QMS into all areas of the organization.
8. Provide training and guidance to staff on quality assurance matters, promoting a culture of quality throughout the organization.
9. Generate comprehensive reports on the performance of the QMS, presenting findings to senior management.
10. Stay updated on industry trends, regulations, and best practices, implementing any necessary changes to the QMS.
Qualifications:
1. Bachelor's degree in Engineering, Quality Assurance or a related field.
2. Minimum of 5 years of experience in a Quality Assurance role within the Engineering industry.
3. In-depth 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 skills, with the ability to identify areas of risk or non-compliance.
7. Strong communication skills, with the ability to explain complex concepts in a clear and concise manner.
8. Excellent organizational skills, with the ability to manage multiple tasks simultaneously.
9. Proficient in Microsoft Office Suite, particularly Excel and PowerPoint.
10. Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) will be an added advantage.
Join us and be part of a team that values quality, innovation, and continuous improvement. We are excited to see your application!
Interested in hearing more? Easy Apply now by clicking the "Quick Apply" button.
Salary
90,000 - 120,000 /year
