QA System Supervisor at Jobot
Santa Clarita, CA 91355
About the Job
QA system Supervisor
This Jobot Job is hosted by: Christopher Mildyn
Are you a fit? Easy Apply now by clicking the "Quick Apply" button
and sending us your resume.
Salary: $80,000 - $110,000 per year
A bit about us:
rapidly growing California-based pharmaceutical company focused on delivering personal care and intimate wellness products in a socially responsible manner through science-based innovation and world-class manufacturing.
Why join us?
Benefits:
401(k)
Dental insurance
Employee assistance program
Flexible schedule
Flexible spending account
Health insurance
Health savings account
Life insurance
Paid time off
Vision insurance
Language:
Spanish (Preferred
Job Details
Job Details:
We are seeking a dynamic and detail-oriented Permanent QA System Supervisor to join our Engineering team. This role presents an exciting opportunity to utilize your skills in a fast-paced, innovative environment. The successful candidate will be responsible for overseeing our quality system, conducting internal and external audits, and managing change control procedures. The individual should have a strong understanding of FDA regulations, ISO 13845 certifications, and 510K submissions. Experience with ERP systems is a must, and bilingual skills are highly desirable.
Responsibilities:
1. Oversee and manage the company's quality system to ensure compliance with industry standards and regulations.
2. Conduct internal and external audits to identify areas for improvement and ensure adherence to quality standards.
3. Implement and manage change control procedures to ensure seamless transitions during system upgrades or modifications.
4. Work closely with the engineering team to understand and address quality issues.
5. Coordinate with cross-functional teams to ensure that quality standards are understood and met.
6. Utilize ERP systems to track, analyze and report on quality metrics.
7. Train and supervise team members on quality system procedures and standards.
8. Prepare and submit 510K submissions as per FDA guidelines.
9. Maintain up-to-date knowledge of industry trends and advancements in quality control and management.
Qualifications:
1. Bachelor’s degree in Engineering or a related field.
2. Minimum of 3 years of experience in a quality assurance supervisory role within the Engineering industry.
3. In-depth knowledge of FDA regulations and ISO 13845 certifications.
4. Proven experience with 510K submissions.
5. Proficiency in using ERP systems.
6. Strong understanding of change control procedures.
7. Excellent leadership and team management skills.
8. Exceptional attention to detail and problem-solving abilities.
9. Bilingual skills are a plus.
10. Ability to work in a fast-paced, dynamic environment.
11. Excellent communication and interpersonal skills.
12. Strong organizational and multitasking abilities.
Interested in hearing more? Easy Apply now by clicking the "Quick Apply" button.
This Jobot Job is hosted by: Christopher Mildyn
Are you a fit? Easy Apply now by clicking the "Quick Apply" button
and sending us your resume.
Salary: $80,000 - $110,000 per year
A bit about us:
rapidly growing California-based pharmaceutical company focused on delivering personal care and intimate wellness products in a socially responsible manner through science-based innovation and world-class manufacturing.
Why join us?
Benefits:
401(k)
Dental insurance
Employee assistance program
Flexible schedule
Flexible spending account
Health insurance
Health savings account
Life insurance
Paid time off
Vision insurance
Language:
Spanish (Preferred
Job Details
Job Details:
We are seeking a dynamic and detail-oriented Permanent QA System Supervisor to join our Engineering team. This role presents an exciting opportunity to utilize your skills in a fast-paced, innovative environment. The successful candidate will be responsible for overseeing our quality system, conducting internal and external audits, and managing change control procedures. The individual should have a strong understanding of FDA regulations, ISO 13845 certifications, and 510K submissions. Experience with ERP systems is a must, and bilingual skills are highly desirable.
Responsibilities:
1. Oversee and manage the company's quality system to ensure compliance with industry standards and regulations.
2. Conduct internal and external audits to identify areas for improvement and ensure adherence to quality standards.
3. Implement and manage change control procedures to ensure seamless transitions during system upgrades or modifications.
4. Work closely with the engineering team to understand and address quality issues.
5. Coordinate with cross-functional teams to ensure that quality standards are understood and met.
6. Utilize ERP systems to track, analyze and report on quality metrics.
7. Train and supervise team members on quality system procedures and standards.
8. Prepare and submit 510K submissions as per FDA guidelines.
9. Maintain up-to-date knowledge of industry trends and advancements in quality control and management.
Qualifications:
1. Bachelor’s degree in Engineering or a related field.
2. Minimum of 3 years of experience in a quality assurance supervisory role within the Engineering industry.
3. In-depth knowledge of FDA regulations and ISO 13845 certifications.
4. Proven experience with 510K submissions.
5. Proficiency in using ERP systems.
6. Strong understanding of change control procedures.
7. Excellent leadership and team management skills.
8. Exceptional attention to detail and problem-solving abilities.
9. Bilingual skills are a plus.
10. Ability to work in a fast-paced, dynamic environment.
11. Excellent communication and interpersonal skills.
12. Strong organizational and multitasking abilities.
Interested in hearing more? Easy Apply now by clicking the "Quick Apply" button.
Salary
80,000 - 110,000 /year