Quality Assurance And Regulatory Affairs
CHROME HEARTS®, the luxury accessories, leather and furniture company renowned for its sophisticated life-inspired designs, was conceived in 1988 by Richard Stark in Los Angeles. Honoring a commitment to quality materials and timeless design, CHROME HEARTS® now has thirty+ stores across North America, Europe, and Asia, and can be found in the most exclusive boutiques around the world.
The Quality Assurance / Regulatory Affairs position is responsible for regulatory compliance needs for Chrome Hearts including the development and implementation of quality systems that will ensure that CH meet current domestic and international regulations and standards.
- Responsible for quality management system updates and implementation.
- Develop and implement appropriate monitoring and inspection systems for receiving work in process, final test, and customer performance.
- Collect and analyze quality data from design, product development, manufacturing, and customer support departments.
- Provide input on safety and quality considerations from all departments as needed.
- Assist with risk assessment.
- Identify any product or process changes to prevent defects.
- Develop, implement, and monitor procedures required to maintain compliance with applicable domestic and international quality system regulation and standards including FDA, ISO and MDR, etc.
- Lead internal quality audits and facilitate corrective actions where appropriate.
- Assist with supplier performance review including trend analysis, investigation and CAPA.
- Analyze customer performance issues that involve Return authorizations and product rejects.
- MoCRA compliance for a line of Cosmetic products in USA.
- Preparation of documents for Cosmetic Product Registration.
- BS degree in engineering or the sciences.
- At least 4 years’ experience in the areas of regulatory affairs, quality assurance, standards compliance, product development and/or manufacturing management for a medical device manufacturing company.
- Proficiency in the use of PC’s and typical software applications including Word, Excel, Outlook, SharePoint, database packages, project management and other applications.
- Excellent communication, organizational and customer relations skills.
- Ability to work independently without supervision to get tasks done.
- Managing other employees is not a requirement.
- Ability to thrive in a fast-paced environment.
- Eager to take on responsibility with a personal sense of accountability.
· 401(k) matching
· Dental insurance
· Health insurance
· Life insurance
· Paid time off
· Vision insurance
Chrome Hearts provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
80,000 - 110,000 / Year