Address
Form of workJob Description
Stable and growing organization within the Medical Device Field!
This Jobot Job is hosted by: Ba Tran
Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume.
Salary: $22 - $28 per hour
We are a premier design, developer, and manufacturer of Medical Device technologies. Our mission is to improve and save people’s lives by innovating and integrating Medical Device technologies into new and existing markets. We are passionate about our commitment to manufacturing quality products and proud about our contributions to the healthcare community. Our ability to work creatively and swiftly allows us to continuously innovate and deliver on our mission!
Job Details:
Join our dynamic team as a Permanent Quality Assurance Technician in the Manufacturing industry, specializing in Medical Devices. This role is integral to ensuring the quality, safety, and efficacy of our lifesaving Medical Devices. You will be part of a team that is committed to making a significant impact on global health by ensuring the highest quality standards in our products. This role requires a thorough understanding of quality assurance principles, a keen eye for detail, and a commitment to continuous improvement.
Responsibilities:
1. Execute and maintain Quality Management System (QMS) in compliance with ISO 13485:2016, FDA 21 CFR Part 820, and AAMI ST79:201.
2. Ensure all operations are conducted in accordance with Good Manufacturing Practices (cGMP) regulations.
3. Perform various inspections and tests throughout the manufacturing process to ensure product quality.
4. Conduct Root Cause Analysis for any product or process non-conformances, and implement corrective actions.
5. Report any non-conformances promptly and accurately, ensuring all necessary documentation is completed.
6. Collaborate with cross-functional teams to implement quality improvement initiatives.
7. Participate in internal and external audits, ensuring readiness and compliance.
8. Maintain up-to-date knowledge of industry standards, regulations, and best practices.
9. Issue Certificates of Conformance for finished products, ensuring all quality standards have been met.
10. Support the company's quality policy and contribute to the strategic direction of the quality management system.
Qualifications:
1. Bachelor's degree in Engineering, Quality Assurance, or a related field.
2. Minimum of 2 years of experience in Quality Assurance within the Medical Device Manufacturing industry.
3. In-depth knowledge of ISO 13485:2016, FDA 21 CFR Part 820, and AAMI ST79:201.
4. Proven experience with cGMP regulations.
5. Experience in performing various inspections and Root Cause Analysis.
6. Strong problem-solving skills with the ability to identify and resolve non-conformances.
7. Excellent written and verbal communication skills, with the ability to effectively report non-conformances.
8. Proficient in the use of quality management systems and other quality assurance tools.
9. Detail-oriented with a commitment to accuracy and thoroughness.
10. Ability to work collaboratively with cross-functional teams to achieve quality objectives.
Join our team and contribute to the development and manufacture of Medical Devices that save lives and improve the quality of life for patients around the world. We look forward to welcoming a committed and dedicated Quality Assurance Technician to our team.
Interested in hearing more? Easy Apply now by clicking the "Apply Now" button.
This Jobot Job is hosted by: Ba Tran
Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume.
Salary: $22 - $28 per hour
A bit about us:
We are a premier design, developer, and manufacturer of Medical Device technologies. Our mission is to improve and save people’s lives by innovating and integrating Medical Device technologies into new and existing markets. We are passionate about our commitment to manufacturing quality products and proud about our contributions to the healthcare community. Our ability to work creatively and swiftly allows us to continuously innovate and deliver on our mission!
Why join us?
- Competitive compensation
- Generous Full Benefits (M/D/V) + 401K
- Awesome work culture
- Accelerated career growth as we continue to expand
Job Details
Job Details:
Join our dynamic team as a Permanent Quality Assurance Technician in the Manufacturing industry, specializing in Medical Devices. This role is integral to ensuring the quality, safety, and efficacy of our lifesaving Medical Devices. You will be part of a team that is committed to making a significant impact on global health by ensuring the highest quality standards in our products. This role requires a thorough understanding of quality assurance principles, a keen eye for detail, and a commitment to continuous improvement.
Responsibilities:
1. Execute and maintain Quality Management System (QMS) in compliance with ISO 13485:2016, FDA 21 CFR Part 820, and AAMI ST79:201.
2. Ensure all operations are conducted in accordance with Good Manufacturing Practices (cGMP) regulations.
3. Perform various inspections and tests throughout the manufacturing process to ensure product quality.
4. Conduct Root Cause Analysis for any product or process non-conformances, and implement corrective actions.
5. Report any non-conformances promptly and accurately, ensuring all necessary documentation is completed.
6. Collaborate with cross-functional teams to implement quality improvement initiatives.
7. Participate in internal and external audits, ensuring readiness and compliance.
8. Maintain up-to-date knowledge of industry standards, regulations, and best practices.
9. Issue Certificates of Conformance for finished products, ensuring all quality standards have been met.
10. Support the company's quality policy and contribute to the strategic direction of the quality management system.
Qualifications:
1. Bachelor's degree in Engineering, Quality Assurance, or a related field.
2. Minimum of 2 years of experience in Quality Assurance within the Medical Device Manufacturing industry.
3. In-depth knowledge of ISO 13485:2016, FDA 21 CFR Part 820, and AAMI ST79:201.
4. Proven experience with cGMP regulations.
5. Experience in performing various inspections and Root Cause Analysis.
6. Strong problem-solving skills with the ability to identify and resolve non-conformances.
7. Excellent written and verbal communication skills, with the ability to effectively report non-conformances.
8. Proficient in the use of quality management systems and other quality assurance tools.
9. Detail-oriented with a commitment to accuracy and thoroughness.
10. Ability to work collaboratively with cross-functional teams to achieve quality objectives.
Join our team and contribute to the development and manufacture of Medical Devices that save lives and improve the quality of life for patients around the world. We look forward to welcoming a committed and dedicated Quality Assurance Technician to our team.
Interested in hearing more? Easy Apply now by clicking the "Apply Now" button.
